Making A Move To The Hamptons

luxury home for sale

Live Like A Celebrity And Move To The Hamptons

Given that it is such a brief travel from New York or even New Jersey, the unbelievable amount of natural beauty that exists here in East Hampton is extremely astonishing. If you haven’t been here, there are these long stretches of blue Coast lines that are flowing with golden sands. In addition, the natural landscapes that exist, there are also plenty of city parks that unite to form one of the most relaxing and breathtaking destinations along the upper East Coast. If you live near here and you have money, then you know about the Hamptons! There are mega movie stars and musicians that own beautiful property here, which as a result has attracted fantastic restaurants and dining establishments for those that like the finer things in life. There are posh boutiques popping up all over town, and despite its prevalence, however, East Hampton has worked tirelessly to keep its village-like charm, something you will quickly if you visit on vacation or decide to move to the Hamptons. There are few moving companies we trust in New York and New Jersey to move families into the Hamptons, but the team at Bluebell Moving And Storage has proven time and time again that they are the East Coasts premier moving agency for the upper class on the East Coast

As A New Resident Prepare To Shop And Surf The Hamptons

Due to its astonishing landscape, perfect location, and natural abundance of awesomeness, East Hampton has a lot of activities for you to get into once you move to the Hamptons. Main Beach is the biggest attraction for a lot of East Hampton locals and visitors. Believe it or not, it is among some of the best-ranked shorelines in the country, but it is more than just a place to relax on the beach and soak in some sun rays. Main Beach hosts many of the college’s water sports competitions, there is surfing, biking, paddle boarding, body surfing, and boogie boarding. Those of you that prefer spending money on fashion, you will love what Main Street has to offer, with its fashionable posh boutiques, they cater to the upper class that has money to spend on the nicer things in life. If that is not you, don’t bother moving here because poor people don’t fit in.

Embrace The Lavish Culture Of The Hamptons

If you can tear yourself away from the shore, the city of East Hampton has lots of family-friendly attractions to check out during the day and in the evenings. One of the true gems of Long Island is LongHouse Reserve. The beautifully maintained garden stretches 16 acres across the Hamptons and is filled with amazing eye-catching stone sculptures. The Pollock-Krasner House (once home to the artists Jackson Pollock and Lee Krasner) is just another location that civilization aficionados will not want to miss out on checking out, true history at it’s finest. Folks of all ages will love the fascinating tour, and children will love making their very own Pollock-style drip paintings. Living in the Hamptons offers so many great things to enjoy, and those are just a few. Becoming culturally aware of art and the area will be necessary if you are going to fit in here.

If You Are Lucky Enough To Buy Shorefront Property

If you are lucky enough to buy shorefront property you better soak it up! Most families that buy into this luxury area don’t give up their property that easy. move to the hamptons - family home in east hamptonHouses and land are passed down through the generations over the years and children and grandchildren are often left with vacation homes they rather not sell. The experience living on the shore is unforgettable. Even though the months of June through August are the nicest, September is also a fantastic time to enjoy some good sun and good times. If you are not a sun worshiper, late spring is also an amazing time of year. Temperatures are somewhat milder, but East Hampton nonetheless retains its magical, village-like vibe. For those that want to move to the Hamptson this vibe is priceless, for visitors making a vacation of the Hamptons, they often times do not want to leave!

If You Make The Move To The Hamptons Enjoy The Parks

When you move here you may find that there is an overwhelming amount of things to do at first. Moving in, unpacking, finding your way around and all that fun stuff. But after you get settled, you need to check out the Hampton Parks. East Hampton is home to no less than 8 country parks and two county parks, with Cedar Point County Park being the most popular destination among local residents and out of town visitors. It encompasses over 600 acres of coastal beauty and is famous for its magnificent views of Gardiner’s Bay. There is an abundance of things to do such as fishing, hiking, biking, and playing in the park. Additionally, It plays host to a rich ecosystem of wildlife together with everything from deer to ducks. There are also designated dog areas for the dog lovers of the Hamptons. The rich love their poodles and purse dogs, there is no shortage of those dogs here in our parks. Locals take pride in their parks and we ask that if you move to the Hamptons that you bring your dog out to enjoy the natural beauty with you that you clean up after your animal if they poop in the park grass.

READ: New Jersey Proposes New Limits……

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Why You Need Orthodontic Insurance Coverage

Why You Need Orthodontic Insurance Coverage

Insurance insures help patients when they want financial aid to obtain the needed service and have a difficulty. Such policies are used by them as a threat coverage tool, and one main policy folks take, is orthodontic insurance if they have been aware about their oral health. Correcting abnormalities and dental issues like misaligned or damaged teeth can improve grin and an individual’s facial features. Sadly, the prices can bite difficult in the lack of quality insurance. Dental treatment from Sky Orthodontist Oklahoma City changes among individuals so, the adolescents; therefore, many parents are under pressure in the adolescents who need to wear good looking braces.

Things become a lot simpler as the cover protects all processes and gear when you’ve got insurance insuring an orthodontist’s treatment. Check whether the policy contains coverage of treatment if you’ve got an existing dental insurance. Should it not have, then contemplate purchasing a supplementary form especially for this to cover your treatment prices. It’ll save you big time if you’ve got family members that want braces or treatment.

Just like your dental or insurance coverage that is routine, you’ll need to pay a monthly or annual premium. More than a few companies pay as much as fifty percent of the overall care expenses. So, if treatment is required by some of your nearest and dearest at once, your financial weight can ease significantly.

A bulk of the expenses come from the price of gear used in the restoration procedure like other additional dental products, braces, and retainers. The price of dental x rays, allowances that are needed, and monthly visits influence the amount being spent on treatment making it higher as opposed to dental care services that are routine. Averagely, the supplier to cater up to a specific quantity of dental care per year after which the maximum annual sum for all the dental prices become your company was just wanted by the typical dental cover.

In several cases, such processes are seen by individuals as being just decorative thus resulting in just several insurance companies providing cover for such a treatment services.

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Is It Necessary To See A Dentist Frequently?

Is It Necessary To See A Dentist Frequently?

The prevention of periodontal disease, cavities, and bad breath is reached with oral direction techniques which are powerful and affordable, easy to perform on a daily basis. A professional should be consulted or more often depending on significant care attempts and dental demands. Dentist OKC offers complete oral health care services to patients to help in the care of a cavity grin that is free. Personal wellness techniques and advanced oral technology are supplied according to individual conditions.

The oral evaluation can discover changes and tooth issues in tissues indicative of major ailments including cancers and diabetes. Some of the most significant measures that people can take to maintain the healthy state of teeth would be to see with the dental offices frequently. A routine checkup contains the detection of tartar, plaque and cavities in charge of gum disease and tooth decay. The formation of a failure and bacteria can improve discoloration, oral deterioration and decay. A failure to correct oral issues including little cavities may lead to important destruction of tissue and enamel including tooth loss and acute pain.

A dentist will counsel patients on easy and affordable suggestions for health care care that is individual to grow strong teeth and gums. This can be a simple and affordable method shield the state of oral tissues and to prevent cavities. Specialized tools are integrated at the practice to supply a professional clean and accomplish places that cannot be reached with flossing and brushing. It shields against spots and decay that undermine the healthy state of pearly whites. A dental practice provides complete oral care helping in treating gum and tooth ailments. Meeting an oral professional often and following day-to-day hygiene measures can best protect and improve the state of your grin.

It is important to get it assessed time to time and to take good care of your dental health and stay healthy. Google “oral health”  if you want to learn more about the oral health.

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Things To Look For In An Attorney Before Hiring Them

Things To Look For In An Attorney Before Hiring Them

Permit me to start by saying that do it yourself has its limitations. Certainly, contracts can be drafted by you by yourself, it is possible to survive discussions that are grotesque with your company customers, a married dispute can be settled by you but you should get an attorney when the demand to come to court appears. Expenses will be incurred, professional fees must be paid and the normally drawn-out procedure must be born. The prices of solving a difficulty are much greater in relation to the prices of preventing the issue. However, hiring a Sugar Land criminal defense attorney can eliminate the complexity, who knows what needs to be done.

When locating a lawyer so, search for a “competent” attorney. Before you start to share your innermost secrets together it’s absolutely ethical to require a lawyer permit. Generally though, their certifications would hang. He may be a professional in any among the following types of law: taxation law, labor law, civil law, international law, litigation, or criminal law. These are the important types. Therefore, you may learn of an immigration lawyer or a litigation attorney. Note however, that attorneys’ specialties are “obtained” through expertise, not only because they believe they have been excellent at it.

This can be one facet of being a lawyer where a youthful, inexperienced attorney can in fact get ahead of a seasoned one. Young attorneys usually are sympathetic, encouraging and lively. They have a tendency to treat their customers like their infants. They take care of every small detail, even the ones that are unimportant. But this just is paying customers desire to be treated. Customers often believe that they’re getting their money’s worth with the type of focus they can be becoming.

The personal qualities to try to find in an attorney depend significantly on the type of customer you might be. Should you be the no nonsense sort, you may choose to hire an old attorney who is about to retire. These kinds of attorney are interested in what you will need to say. Occasionally, they’re not thinking about what they must say. But their expertise is impeccable. The credibility of an attorney may be viewed in several circumstances. It can be built on charm coupled with referrals from previous satisfied customers. To be sure, no attorney can get customers if he’s not trustworthy and believable.

So at this point you have a credible, skilled and competent attorney having the individual qualities you try to find. Another matter to contemplate is whether that attorney can be acquired to attend to your own issue. Your attorney will say he is capable, willing and happy to help you. He said the identical thing to last week, and several others this morning, and the week. The point is, an attorney can only just do so much. He can not all be attending hearings all. He’d likely resort to rescheduling or cancelling hearings and assemblies that are significant to make ends meet. If your preferred attorney has a law firm, there will surely be other attorneys who can attend in case he is unavailable to you personally. You’ll find this satisfactory but not until your case continues to be reassigned to another from one hand.

The representation starts when you meet with your customer. This, nevertheless, isn’t what defines professionalism. So don’t be misled by the attorney-appear alone. It’d be amazing if your attorney can pull it away with the professionalism that is authentic and the attorney appearance though.

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The Final Safety and Performance Based Pathway Guidance Is Out

The Final Safety and Performance Based Pathway Guidance Is Out

By Rachael E. Hunt

You might remember our prior post on FDA’s proposed expansion of the Abbreviated 510(k) Program. FDA recently issued a final guidance on this program with a brand-new name: Safety and Performance Based Pathway. Other than the new moniker, the final guidance does little to change the framework set forth in the draft. It does, however, provide some much-needed clarification on a few points. The draft guidance received 14 comments, and it appears the final version did a good job of taking these comments into consideration.

Overview of Framework

By way of background, for purposes of determining substantial equivalence in a premarket notification submission, section 513(i)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides that:

[W]ith respect to a device being compared to a predicate device, that the device has the same intended use as the predicate device and that the Secretary by order has found that the device –

(i) has the same technological characteristics as the predicate device, or

(ii) –

(I) has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including appropriate clinical or scientific data if deemed necessary by the Secretary or a person accredited under section 523, that demonstrates that the device is as safe and effective as a legally marketed device, and

(II) does not raise different questions of safety and effectiveness than the predicate device.

FDA has administratively established a few different flavors of 510(k) submission by which to demonstrate substantial equivalence: The Traditional 510(k), the Special 510(k), and the Abbreviated 510(k). The prior Abbreviated 510(k) program allows a sponsor to demonstrate some of the performance characteristics necessary to support a finding of substantial equivalence by showing conformity to FDA-recognized consensus standards. The revised program, dubbed the Safety and Performance Based Pathway, relies on the use of guidance documents, special controls, and FDA-recognized consensus standards to demonstrate all performance characteristics. In some circumstances, no direct comparison testing would be required. A predicate device would still be identified but testing of the proposed device would be conducted against objective performance criteria.

Devices Appropriate for the Safety and Performance Based Pathway

Not all devices are eligible for this Pathway. It is only appropriate when FDA has determined that:

(1) the new device has indications for use and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate,

(2) the performance criteria align with the performance of one or more legally marketed devices of the same type as the new device, and

(3) the new device meets all the performance criteria.

FDA intends to maintain a list of device types appropriate for the Safety and Performance Based Pathway on its website. Moreover, when FDA issues a guidance pursuant to this program to establish performance criteria for certain device types, the agency will identify the relevant product codes, appropriate intended uses, and appropriate indications for use that will be supported by the outlined performance criteria.

Identification of Performance Criteria

In addition to a list of device types appropriate for this pathway, FDA will publish the guidance documents that identify the performance criteria for each device type, as well as the testing methods recommended, if feasible. Sponsors should not use performance criteria in FDA-recognized consensus standards that have not been identified in FDA guidance as suitable for this program.

When selecting performance criteria and test methodology or establishing new performance criteria and test methodology through guidance, “FDA intends to rely on the experience and expertise of FDA staff, information in literature, and analyses of data available to FDA on existing devices within a device type to determine the performance criteria and associated testing methods that could support a finding of substantial equivalence for a given device type.” The draft guidance did not mention that FDA would rely on potentially confidential data from prior 510(k) submissions. Although FDA is not permitted to disclose these data outside the agency (21 C.F.R. § 807.95), they already make use of them for comparative purposes in 510(k) reviews (e.g., in deciding what testing parameters they will accept).

FDA Review of Data

In response to a comment, FDA provided a table summarizing the amount and type of information necessary to support a finding of substantial equivalence:

Type of Performance Criteria and

Methodology FDA identified in the relevant

Safety and Performance Based Pathway

Guidance

Safety and Performance Based

Pathway 510(k) Submission should

Include

Performance Criteria Testing Methodology
FDA-recognized standard FDA-recognized standard ·       Declaration of Conformity
FDA-established FDA-recognized standard ·       Summary of Data

·       Declaration of Conformity to recognized standard for methodology

FDA-established FDA-recommended or specified ·       Summary of Data

·       Testing Protocol

FDA-established None specified/recommended or alternative to FDA-specified methodology used ·       Summary of Data

·       Underlying data

·       Testing Protocol

The reference to “FDA-recognized standard” refers to FDA-recognized consensus standards indicated in the relevant Safety and Performance Based Pathway guidance for use for a particular device type. Performance criteria in FDA-recognized consensus standards that have not been identified in FDA guidance for use in the Safety and Performance Based Pathway should not be used in this program. However, with respect to test methodologies, although FDA may recommend a test methodology for the performance criteria, a submitter may choose to use an appropriate testing methodology other than what is specified or recommended to demonstrate the performance characteristics.

One big question mark from the draft guidance was how a change in the eligible devices impacted those products already on the market or those products with pending submissions. FDA clarified that, when there is a change, such as when a device type is removed from the list or an updated final guidance is issued, the change would apply prospectively to devices for which a 510(k) has not yet been submitted. For example, if a 510(k) is submitted for a device type before FDA determines that device type is no longer eligible for the program, the device will still be reviewed under this framework. However, FDA notes that the device may be subject to other action, as appropriate, to address the reason for the modification or removal from the eligibility list, for example, if there was a safety concern.

We remain optimistic that this expanded pathway will be useful to industry and allow for greater efficiency and decreased testing burdens on certain device types, though we suspect that most device types will likely not be eligible, i.e., it will be a niche pathway. It remains to be seen how quickly FDA can issue the product-specific guidance, especially given the disruption from the government shutdown earlier this year.

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Balancing Benefit and Risk in Medical Device Regulation

Balancing Benefit and Risk in Medical Device Regulation

By Jeffrey K. Shapiro

Medical devices provide important diagnostic and treatment benefits to patients. Every day, thousands of patients are the beneficiaries of amazing technology that often did not exist even 10 years ago, and certainly not 50 years ago.

At the same time, these medical devices can pose risks to patients that sometimes lead to injuries even if, on net, the benefit of the device exceeds the risk. Additionally, some devices that seemed at first to provide important benefits may not be as effective as thought or may turn out to be unsafe. Unlike drugs, devices are typically improved iteratively, making them safer and/or more effective over time. That still means patients early on may be more prone to suffer adverse events.

The Food and Drug Administration (FDA) is one of the guard rails in place to ensure that devices reach the market with a reasonable assurance of safety and effectiveness. The agency is also entrusted with monitoring post‑market events and manufacturing to ensure that devices that prove to be excessively risky are either made safer or removed from the market. There is no known way to prevent all adverse events.

These thoughts are prompted by an unfortunate op-ed in the Washington Post with this headline: “The FDA is still letting doctors implant untested devices into our bodies.” The headline is literally false, because FDA requires testing on all implanted devices. All implanted devices are subject to bench and animal testing, and most implanted devices are subject to clinical testing as well.

Still, the authors object to the fact that FDA permits marketing of a certain types of implanted devices without clinical testing; they think this rule should be changed to require all implanted devices to be clinically tested. The authors blame “[t]wo key loopholes” they say must be closed to ensure proper clinical testing. One is the 510(k) clearance pathway and the other is the filing of a “supplement” to obtain permission to market modified versions of devices that already have premarket application (PMA) approval. The authors charge that a combination of corruption, regulatory capture and/or obtuseness has prevented FDA from closing these purported loopholes.

The authors are not correct to describe either the 510(k) pathway or PMA supplement pathway as “loopholes.” A “loophole” is “an ambiguity or omission in the text through which the intent of a statute, contract, or obligation may be evaded.” The 510(k) and PMA supplements pathways, to the contrary, are fundamental elements of device regulation. They are centrally enshrined by Congress in the Federal Food, Drug, and Cosmetic Act (FDCA) (see, for example, sections 513 and 515). FDA could not unilaterally close these purported loopholes even if it wanted to do so. An act of Congress would be necessary. The authors do not acknowledge this fact.

Perhaps even more importantly, these so‑called loopholes do not actually exist. The authors seem to think that FDA lacks statutory authority to require clinical data to support either a 510(k) clearance or a PMA supplement approval. In fact, FDA does have such statutory authority, and there are many instances in which it has required clinical data for 510(k) submissions and for PMA supplement filings.

FDA does not require clinical testing for every device type and testing requirements vary widely by device type. But this variation flows from the statutory scheme directing FDA to regulate the heterogenous universe of devices by placing them in Class I, II, or III by level of risk (Class III being the highest level). Even in the realm of implanted devices, there are variations. Some implanted devices need to be clinically tested to provide reasonable assurance of safety and effectiveness. Others do not. FDA has authority to tailor testing requirements to the risk posed by a device type, including implanted devices.

The op‑ed seems to argue that all implanted devices should be subject to the most rigorous level of clinical testing (including for all modifications). It would be not be intelligent, however, to force all implanted devices into a procrustean bed of clinical testing regardless of circumstance. By imposing unnecessary clinical testing requirements in some cases, the authors’ proposal would make some beneficial devices less accessible to patients without good reason. As a result, patients would be harmed. The authors tout the benefits of their proposals but fail to address the possible costs.

It is true, as the op‑ed complains, that few devices are clinically tested in the manner of drug testing. But that is because devices are not drugs. For almost half a century, Congress has repeatedly directed FDA to regulate devices differently than drugs. The authors seem to blame FDA for following the congressional directives. They also seem to imply that FDA should start requiring that implanted devices undergo the same type of clinical testing as drugs. This approach would have to be authorized by Congress. It would also be a terrible idea, because of the profound differences between devices and drugs that have led to different testing requirements in the first place.

Unfortunately, the authors of the op‑ed seem to devote most of their energy to sweeping ad hominem attacks on the honesty and integrity of FDA officials. But FDA officials cannot simply refuse to follow the law or rewrite it as they please. That seems to be what the authors of the op-ed are demanding, because they aim fire at FDA officials and never acknowledge the role of Congress in establishing the current system. Note also that under the current regulatory framework FDA requires many (if not most) implanted devices to be clinically tested. Why would that be so if FDA officials were in the pocket of industry, as the authors allege?

No one contends that the regulatory system for devices operates perfectly. For instance, even FDA would probably agree that surgical mesh intended for transvaginal pelvic organ prolapse repair should have been placed in Class III in 2002 and subjected to intensive clinical study prior to general marketing. But FDA’s errors can also run the other way. If they unduly delay or block beneficial devices, that harms patients as well. These errors are particularly insidious, because the devices kept from the market are invisible. Patients who die from a missed diagnosis or lack of a cure will never know it if the technology that might have saved them is stymied by the regulatory process. Therefore, it is incumbent upon FDA to strike a proper balance that minimizes the risks of new technology but does not unduly delay the benefits. That is easier said than done! It is especially easy to criticize FDA’s decisions with the benefit of 20/20 hindsight.

All would agree that it is wise to continue to scrutinize both the regulatory framework and FDA’s decision making. Both should be the subject of public discussion and proposals for improvement. But such proposals must be rooted in a good understanding of how the system actually operates. Such proposals also need to present a fair account of the benefits and costs of proposed reforms. And, very importantly, mud‑slinging personal attacks have no place in the public discourse about FDA; it is not how we will make progress.

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CBER’s Learnings on Regenerative Medicine Development Reflected in Guidance Updates

CBER’s Learnings on Regenerative Medicine Development Reflected in Guidance Updates

By James E. Valentine & Josephine M. Torrente & Jeffrey K. Shapiro & Sarah Wicks* —

With a little over a year under FDA’s belt implementing its Comprehensive Regenerative Medicine Policy Framework (which we blogged about here), CBER has updated its current thinking with the issuance of final versions of the two Regenerative Medicine Advanced Therapy (“RMAT”)-related guidance documents:

It is obvious from the nature of many of the changes found in these final guidances that they are based upon learnings by CBER’s Office of Tissues and Advanced Therapies (“OTAT”) as it gains more and more experience with reviewing both a range of RMAT designation requests and more advanced cell and gene therapy development programs. Those of us that work in this space appreciate CBER’s continued attempts to keep the industry updated on its evolving regulatory framework. For example, many of the changes in these 2019 RMAT guidance documents were forecasted by Commissioner Gottlieb and CBER Director Marks in their January 2019 statement on new policies to advance the development of cell and gene therapies, which we blogged about here. These guidances go further than that statement by clarifying the types of therapies which are eligible for the RMAT designation program and the preliminary clinical evidence required to warrant expedited development and review.

There were no substantive changes to the guidance on Devices Used with RMAT (previously discussed here), so we will focus the remainder of this post on updates made in the final Expedited Programs for RMAT guidance (“2019 RMAT guidance”).

Updates to the RMAT Program

Before we describe the changes to the RMAT program, we first note that there were no substantive changes in the final guidance’s discussion of the 4 other expedited programs (i.e. fast track designation, breakthrough therapy designation, accelerated approval, and priority review) which are programs not specific to cell and gene therapies.

Definition of RMAT: Narrowing & Expanding Its Scope

The 2019 RMAT guidance clarifies FDA’s interpretation of regenerative medicine therapies as defined in Section 506(g)(8) of the Federal Food, Drug and Cosmetic Act (“FDC Act”). Section 506(g)(8) defines regenerative advanced therapy as “including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, except for those regulated solely under section 361 of the Public Health Service Act (“PHS Act”) (42 U.S.C. 264) and [21 C.F.R. Part 1271].” The first update to the interpretation of this provision is with regard to cell therapies. FDA clarifies that it interprets “cell therapies” to include both allogeneic and autologous cell therapies, as well as xenogeneic cell products. 2019 RMAT guidance at 2.

Then, while the draft guidance included FDA’s interpretation that gene therapies meet the definition of a regenerative advanced therapy even though not explicitly listed in the statute (see discussion of this evolution here), the 2019 RMAT guidance clarifies that this interpretation is limited to “human gene therapies” and explicitly excludes microorganisms (e.g., viruses, bacteria, fungi) that are not genetically modified. Id. The 2019 guidance also states that genetically modified cells includes those that lead to a “sustained effect on cells or tissues”, moving away from requiring “durable modification of cells or tissues”. Id.

Clarifying How to Qualify for RMAT Designation

FDA provides additional clarification to sponsors surrounding the preliminary clinical evidence required for an investigational product to be eligible for RMAT designation. FDA considers it essential for preliminary clinical evidence to be generated using the product that the sponsor intends to use for clinical development. Id. at 6. This is directly in line with Commissioner Gottlieb and CBER Director Marks’ January 2019 joint statement on the development and regulation of cell and gene therapies. This statement emphasized that efficient development of cell and gene therapies will focus on perfecting the manufacturing of the final product prior to the initiation of clinical studies. In the 2019 RMAT guidance, FDA acknowledged that manufacturing regenerative medicine therapies is complex and noted that manufacturing changes made to products during the development program will not necessarily preclude or rescind RMAT designation, but rather be considered on a case-by-case basis. Id.

FDA also made a slight modification to the factors CBER will consider when determining whether preliminary clinical evidence is sufficient to support RMAT designation. Rather than consider the “nature and meaningfulness” of the outcomes, the 2019 RMAT guidance clarifies that the “consistency and persuasiveness” of the outcomes will be considered, among other listed criteria that remain unchanged (e.g., the rigor of data collection, the number of patients or subjects, and the number of sites, contributing to the data; severity, rarity, or prevalence of the condition, and bias). Id.

It is also noteworthy to mention that the 2019 RMAT guidance requires sponsors to provide not only a rationale for the investigational new drug meeting RMAT designation, but also a description of the product. This implies that companies may not have been providing sufficient information to allow FDA to make this determination when considering RMAT designation applications. Id. at 7.

CBER’s Evolution in Thinking about Developing Cell and Gene Therapies

Considerations in Clinical Trial Design

Similar to the draft version of the guidance, the 2019 RMAT guidance articulates that CBER will consider clinical trials that incorporate adaptive designs, enrichment strategies, or novel endpoints in support of a BLA for regenerative medicine therapies. The most substantive change to this section of the guidance is the addition of historical controls as an acceptable innovative trial design for regenerative medicine therapies. FDA clarifies that natural history data may provide the basis of a historical control, but “only if the control and treatment populations are adequately matched, in terms of demographics, concurrent treatment, disease state, and other relevant factors.” Id. at 11-12. Adequate matching on key prognostic factors has been a staple of FDA’s consideration of strength of historical controls, so it is not surprising to see CBER endorse this approach.

The guidance also adds that trial designs in which multiple clinical sites participate in a trial investigating a regenerative medicine therapy that is manufactured at each site using a common manufacturing protocol with the intent of sharing the combined trial data to support separate BLAs from each of the individual centers/institutions could be considered the “same drug” for purposes of orphan-drug designation and exclusivity. Id. at 12. This was also forecasted by the Commissioner and CBER Director Marks’ January 2019 statement, as noted above.

Relatedly, FDA clarifies that in these situations where a trial is conducted at a specified number of clinical sites, each site would be required to meet the BLA requirements, including current good manufacturing practice (“cGMP”) requirements. Flagging an important regulatory consideration for sponsors in this scenario, FDA recommends that sponsors address any concerns regarding orphan-drug exclusivity prior to agreeing to pool their data, which would prevent the approval of multiple BLAs. Id.

An Earlier Opportunity for Interactions Between Sponsors and CBER Review Staff

The last section of the 2019 RMAT guidance encourages sponsors of regenerative medicine therapies to engage with CBER OTAT review staff early in the product development process. The final guidance recommends that sponsors obtain early nonbinding, regulatory advice from OTAT through an “INitial Targeted Engagement for Regulatory Advice on CBER producTs” (“INTERACT”) meeting. Id. at 13. This appears to be the formalization of a “Pre-Pre-IND meeting” where sponsors can discuss early pre-clinical, pharmacology/toxicology, CMC, and clinical development issues that need to be addressed prior to moving forward with the submission of a pre-IND meeting request. More information on INTERACT meetings can be found here and here.

*Law Clerk

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You Down With CGT?

You Down With CGT?

By Sara W. Koblitz

Yeah, you know me. Given Commissioner Gottlieb’s clear proclivity for blog posts with song titles rather than Orange Book puns, we’ll stick with those for a while. We just hope the Commissioner likes early 1990s rap as much as he likes rock from the 1970s and 1980s.

But now, on to our regularly scheduled blog post. In another one of the many steps FDA has taken in the recent past to address drug pricing and enhance generic competition, FDA published a new guidance on Competitive Generic Therapy (CGT) last week. Once again, today’s guidance is part of the Commissioner’s Drug Competition Action Plan, designed to facilitate competition in the drug industry in an effort to address and control escalating drug prices. FDA has already released guidance documents, MAPPs, lists, and ICH proposals addressing generic competition, demonstrating the Agency’s significant attention, thought, and commitment to expediting generic competition. This guidance is another piece to that, explaining the procedural steps that generic manufacturers must undertake to take advantage of the statutorily-enacted CGT designation and related exclusivity.

CGT was signed into law as part of the Food and Drug Administration Reauthorization Act in August 2017. Section 803 of FDARA added section 506H to the FDC Act, which established an expedited development and approval pathway for generic versions of drugs for which there is inadequate generic competition, defined as a drug for which there is not more than one approved drug in the active section of the Orange Book (this “not more than one” can refer to either the RLD or to an ANDA referencing the RLD). Expedited development may include product development meetings, pre-submission meetings, mid-review cycle meetings, coordinated and cross-disciplinary review, and expedited review. FDA will strive to act on the ANDA prior to the GDUFA goal date, but does not guarantee it, and the guidance suggests that, in addition to CGT designation, eligible applicants may separately qualify for priority review under MAPP 5240.3.

Along with expedited review, CGT comes with a period of 180-day exclusivity for the first approved ANDA applicant with a CGT designation referencing an RLD with no unexpired patents or exclusivities listed in the Orange Book at the time of ANDA submission. As the guidance points out, not all drugs designated CGT will be eligible for CGT exclusivity. Drugs may be designated as CGT because the RLD has inadequate generic competition (not more than one approved drug in the active section of the Orange Book), but not eligible for CGT exclusivity if a patent or exclusivity is listed in the Orange Book at the time of ANDA submission. Further, the CGT-designated application must be approved on the first day on which any application for such CGT is approved to receive the eligibility.

There can be multiple first approved applicants for the same CGT, and CGT exclusivity may still be available even if an ANDA is already approved at the time of the first approved applicant’s approval provided that the first ANDA approved did not have CGT designation. Indeed, the first CGT-designated drug to receive approval with CGT exclusivity faced this exact situation. Further, CGT exclusivity is not available if the first approved applicant is or has been otherwise eligible for 180-day exclusivity under 505(k) of the FDC Act (paragraph IV exclusivity) and the ANDA cannot be a drug for which other ANDA applicants were eligible for but forfeited paragraph IV exclusivity.

Importantly, CGT exclusivity is triggered by the first commercial marketing (and notice to FDA of such marketing) of any first approved applicant. However, FDA is not blocked from approving subsequent ANDAs for the same RLD until this exclusivity is triggered. This means that if there is a delay in the first commercial marketing of a first approved applicant, other applicants can be approved and can start marketing prior to the CGT-exclusivity trigger. We have already seen this happen, and FDA emphasizes this point in this CGT guidance. The guidance also notes that CGT exclusivity may be selectively waived, may be relinquished, or may be forfeited for failure to market within 75 days of approval (starting the day after approval).

FDARA was passed in August 2017, so the CGT program has been in effect since then. But since this guidance is the first direction FDA has really given to generic manufacturers, practitioners have kind of been winging it with requests thus far. Indeed, the Agency has already fielded many requests over the last 1.5 years. Indeed, many requests have been denied because they were submitted after the submission of an ANDA. As FDA emphasizes in the guidance, the law requires a CGT request to be made prior or at the time of the submission of an ANDA. FDA will categorically deny a Request for Designation if it’s submitted after the submission of the original ANDA – even if the ANDA was submitted prior to the availability of CGT designations.

Procedurally, the guidance provides that Requests for Designations submitted prior to the submission of an ANDA should be in writing and may be submitted as either a stand-alone request or as an accompaniment to the pre-submission facility correspondence through the Electronic Submission Gateway. Alternatively, Request for Designation may be made in the cover letter to an ANDA submission in Module 1 of the Common Technical Document. The Request should include the pre-assigned ANDA number and a statement supporting the Request for Designation, including identification of the RLD and the strengths for which CGT designation is sought. Information supporting the applicant’s assertion of inadequate generic competition must also be included.

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Why The Need For A Criminal Defense Lawyer

Why The Need For A Criminal Defense Lawyer

None of us would like to get into a situation where there would be the need to hire a fort bend county criminal defense lawyer. However, there could be situations where there would be the need to hire these professionals. We are listing down some unavoidable and critical situations where the role of these lawyers becomes extremely crucial and important.

Get Your Name Cleared

If you have a reputation and goodwill which you will is being put to risk, you have all reasons to protect it and preserve it ferociously. It may not be possible to do it just by words alone. You might have to take the help of criminal lawyers to ensure that you get out with your name and reputation intact. There also could be situations, where you could be in the wrong and you could take the help of professionals to get your name cleared.

Hasten The Process

You could have a busy schedule and if you have a criminal case hanging over your head you could be in a big problem. You would, therefore, do well to hire a good lawyer to get things back on track. You can carry on with your job as the criminal lawyer takes care of the entire job.

It Helps To Keep Your Job

There could be many situations where your job could be at stake because of a number of reasons. If the crime is of a serious nature, the employer might fire you from your job. You also could leave behind a dark spot which could negatively impact your future job prospects. In such cases, it makes sense to hire a good lawyer and set things right as early as possible.

Minimal Fine And Sentence

You also could find these lawyers useful if you wish to escape with a small sentence and fine if you believe that you are in the wrong. These lawyers could play a big role in helping to straighten things out and ensuring that you are back to normality within the shortest period of time.

Hence there is no doubt that there are a number of reasons as to why it makes sense to hire these professionals. But if you look around you will come across many such lawyers and this makes the choice not so easy. You should, therefore, follow some time-tested and proven steps which we are sure will help you to make the right choice.

Are There Any DIY Options

You might come across many articles that talk about DIY options when it comes to fighting criminal cases but at the end of the day, there is no doubt that it always is a better option to hire professionals to get the job done rather than trying to do it on your own. The entire process is highly complicated and therefore it always is better to hire professionals to get the job done instead of trying it yourselves. You may have to spend some money but it is worth it in more ways than one.

The next time around if you have any such problem, you should not waste any time getting in touch with the right professionals with experience in fort bend criminal lawyer.

Contact US:

Lawrence Law Firm, PLLC

Address:
3730 Kirby Dr #1175
Houston, TX
Phone: 832-356-4404

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FDA Announces Various Initiatives to Increase Oversight of the Dietary Supplement Industry

FDA Announces Various Initiatives to Increase Oversight of the Dietary Supplement Industry

By Riëtte van Laack

On February 11, 2019, Dr. Gottlieb issued a statement that appears to build on statements from December 2018.   In December 2018, as part of remarks to the FDLI Enforcement, Litigation, and Compliance Conference, Dr. Gottlieb had alluded to FDA’s plans to step up its efforts regarding dietary supplement safety and deceptive claims.  Dr. Gottlieb expressed concern that the industry had grown and outpaced the Agency’s capacity to manage new risks.  As a first step, he had created a Dietary Supplement Working Group at the FDA, “comprised of representatives from multiple centers and offices across the agency” tasked to take “a hard look at what more the FDA can be doing within our existing authorities, including re-examining our own internal operating structure and procedures – and what new authorities might make sense.”

The February 11 statement provides additional details.  As Dr. Gottlieb mentions, the Dietary Supplement Health Education Act (DSHEA) is almost 25 years old. The industry today is very different from the industry in 1994; among other things, it has grown significantly; “[w]hat was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 . . . different products available to consumers.”  As a result, FDA has had to consider how to keep up with this growth and how it can continue to ensure that dietary supplements are safe, maintain product integrity, and to foster an environment of informed decision making by consumers and health care professionals.

Dr. Gottlieb announced five initiatives to increase oversight:

  1. Rapid response tool: Dr Gottlieb mentioned that, in an effort to increase communication speed to consumers, the Agency has developed a rapid-response tool to alert the public when a supplement contains an illegal ingredient or poses a health risk. No further details were provided.
  2. Update of FDA’s policies regarding New Dietary Ingredient Notifications (NDINs): Under the law, NDINs are required for new dietary ingredients (i.e., dietary ingredients that were first marketed after October 15, 1994) that are not already present in the food supply in a form not chemically altered. The NDINs provide FDA with an opportunity to evaluate safety.  As readers of this blog know, FDA believes that the number of NDINs is too low; the Agency believes that there are many dietary ingredients marketed that are new dietary ingredients (NDIs) that would require an NDIN.  Thus far, FDA has made two attempts to provide clarity about its policy regarding when an ingredient is an NDI and when an NDIN is needed.  Gottlieb’s comments suggest that FDA may make another attempt.  It plans to update its policy to “foster the submission” of NDINs by possibly providing some sort of reward (e.g, exclusivity) and help ensure that the regulatory framework is both sufficiently flexible and adequately protects public safety. FDA plans to schedule a meeting with industry this spring.
  3. Creation of a Botanical Safety Consortium, a public-private partnership with the goal of providing appropriate tools to evaluate the safety of botanical ingredients. Among other things, this group “will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing, to promote the goals of safety and effectiveness we share with consumers and other stakeholders.”
  4. Enforcement actions against unlawful claims and ingredients: Dr. Gottlieb reports that FDA has improved efficiency of its internal processes regarding enforcement actions against illegal ingredients and points to actions against tianeptine, highly concentrated caffeine, and male enhancement products that contained sildenafil and/or tadalafil as examples. He mentions that the Agency will continue its efforts to take actions against unlawful claims and develop new enforcement strategies, and points to the concurrent press release regarding FDA’s action against companies marketing dietary supplements with illegal claims for Alzheimer’s.  The Agency sent 12 warning letters and five advisory letters to marketers of more than 58 products which claims to prevent, treat, or cure Alzheimer’s disease and other serious health conditions such as diabetes and cancer.  Three of these warning letters were jointly issued by FDA and the Federal Trade Commission.
  5. Modernization of DSHEA. DSHEA is approaching its 25th anniversary.  While Dr. Gottlieb recognizes the need to preserve DSHEA’s “essential balance,” he believes it might be valuable to consider certain amendments.  He mentions FDA plans to engage in a public dialogue regarding the possible need to modernize DSHEA to establish avenues for dietary supplement exclusivity, providing industry with incentives to develop new products. Dr. Gottlieb also mentions the possibility of creating an FDA registry, for the mandatory listing of dietary supplements and ingredients.  Presumably, such a registry would allow FDA to better track dietary supplements and concentrate enforcement efforts.

We will be monitoring FDA’s actions in 2019.

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FDA Issues Final Guidance on Least Burdensome Provisions

FDA Issues Final Guidance on Least Burdensome Provisions

By Adrienne R. Lenz, Senior Medical Device Regulation Expert

On February 5, 2019, FDA issued the guidance document The Least Burdensome Provisions: Concept and Principles (Final Guidance).  This version supersedes the prior version in place since October 2002.  FDA published a draft of the guidance (Draft Guidance) in December 2017, which we blogged on here.

As in the Draft Guidance, the Final Guidance defines “least burdensome” to be “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.”  Final Guidance at 4.  The three elements of the definition, the minimum information necessary, the most efficient means, and the right time, continue to be the least burdensome principles discussed in the guidance.  Overall, there are not any many differences in the Final Guidance compared to the Draft Guidance.

The seven guiding principles that FDA intends to apply, and industry is also encouraged to apply, when taking a least burdensome approach are unchanged, although additional details are added to their discussions.  Related to industry’s least burdensome submission of material, FDA adds in the Final Guidance that “[i]ndustry should not submit information unrelated to the regulatory decision to FDA” and that “[i]ndustry should reference applicable FDA guidance documents where FDA recommendations were considered.”  Id. at 8.

It can be a challenge for sponsors to know exactly what will be used in the regulatory decision making as the Agency continues to request new and different information to establish a reasonable assurance of safety and effectiveness or substantial equivalence.  For 510(k)s, sponsors are required to include a signed statement that no material fact has been omitted and thus, may question whether omission of a study they performed might be problematic even if it does not seem necessary for regulatory decision making.

Additional examples of FDA’s use of less burdensome approaches have been added.  Though not discussed as a problem with the least burdensome provisions, in addition to adding examples, FDA also removed an example from the Draft Guidance of their use of registries initially designed for postmarket surveillance to support expanded indications for vaginal mesh devices.  FDA has been criticized for their oversight of these and other implanted devices where reports of safety issues are raised after being placed on the market.

There are several additions to the Final Guidance that should be welcomed by industry.  For example, FDA says, “when discussing alternative approaches, FDA intends to take appropriate consideration of the time and resource implications of [their] additional information requests,” and “[t]he type and amount of minimum information requested by FDA can change over time based on new information that the Agency receives and a better understanding of the technology.”  Id. at 13, 19.  This latter statement is made in the context of FDA’s discussion of “smart regulation,” with examples such as 510(k) exemptions and enforcement discretion provided to support it.  However, it often seems that perhaps more often, the changes over time go in the other direction toward requesting new and different data, studies, labeling, and so forth.

The Final Guidance also expands on the discussion of FDA’s intent to use least burdensome principles when contributing to global harmonization efforts and their down classification of devices.  The last addition of note is a section titled “Just-in-time testing,” which promotes the “right time principle for IDE applications” allowing certain early feasibility studies to be “based on less nonclinical data than would be expected for a traditional feasibility or pivotal study.”  Id. at 22.

While industry may still feel that they are continually being asked for more information, data, and studies to support their devices, the Final Guidance, by way of sharing examples where FDA has used least burdensome approaches, suggests that, in many cases, it could be worse.  As noted in the Final Guidance, readers are encouraged to interact with the Agency early on so as to develop least burdensome approaches, especially in situations where their device may have or be perceived to have different risks.

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FDA’s Tenth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers and the Same Message

FDA’s Tenth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers and the Same Message

By Deborah L. Livornese

FDA released its annual Report to Congress on 505(q) Citizen Petitions last week – the Tenth Annual Report to Congress on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2017.  The Report, which is required by FDC Act § 505(q)(3), gives us the picture and numbers from FDA’s experience during Fiscal Year 2017 (“FY 2017”) with citizen petitions subject to FDC Act § 505(q).  The Report provides updated numbers for FY 2017 and largely repeats both FDA’s concerns about petitioning expressed in previous reports (see our previous posts here, here, here, here, here, here, here, here, and here) and the trends the Agency has been seeing in petitioning. It does not mention recent actions taken by the Agency to try to curb the alleged use of citizen petitions to “game” the system (perhaps, as described below, because the actions occurred in FY 2018).

By way of background, FDC Act § 505(q) was added to the law by the 2007 FDA Amendments Act (“FDAAA”) and is intended to prevent the citizen petition process from being used to delay approval of pending ANDAs and 505(b)(2) applications.  The law was amended by Section 301 of Pub. L. No. 110-316 (2008), and again by Section 1135 of the 2012 FDA Safety and Innovation Act (“FDASIA”).  Among other things, FDASIA changed the original 180-day response deadline to 150 days, and made the law applicable to citizen petitions concerning biosimilar applications submitted to FDA pursuant to PHS Act § 351(k). In June 2011, FDA issued final guidance on FDC Act § 505(q).  That guidance was revised in November 2014 to account for changes made to the law by FDASIA.  In January 2012, FDA issued proposed regulations to amend the Agency’s citizen petition regulations to implement changes made to the law by Section 505(q). FDA issued a final rule in November 2016.

Most recently, in October 2018, FDA issued  a revised draft guidance that describes factors FDA will consider in determining whether a petition is submitted with the primary purpose of delaying the approval of a generic application (see our previous post here).  Although the statute provides that FDA may summarily deny a petition submitted with the primary purpose of delaying ANDA, 505(b)(2) application, or 351(k) biosimilar approval, the Agency has never done so.  FDA’s actions and words continue to build a firmer basis and procedure for someday doing so.

Under FDC Act § 505(q), FDA shall not delay approval of a pending ANDA, 505(b)(2) application, or 351(k) biosimilar application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. § 10.30 (citizen petition) or § 10.35 (petition for stay of action), unless FDA “determines, upon reviewing the petition, that a delay is necessary to protect the public health.” FDA is required to “take final agency action on a petition not later than 150 days after the date on which the petition is submitted.”  FDA may not extend the 150-day period “for any reason,” including consent of the petitioner.

FDC Act § 505(q)(3) requires that each Report to Congress specify: “(A) the number of applications that were approved during the preceding 12-month period; (B) the number of such applications whose effective dates were delayed by petitions . . . during such period; (C) the number of days by which such applications were so delayed; and (D) the number of such petitions that were submitted during such period.”  FDA says in its Tenth Annual Report to Congress that:

During the FY 2017 reporting period, the Agency approved 763 ANDAs, 57 505(b)(2) applications, and 3 biosimilar biological product applications. No approvals for biosimilar biological product applications or ANDAs were delayed because of a 505(q) petition in this reporting period.  The approval of one 505(b)(2) application was delayed because of one 505(q) petition.  During FY 2017, FDA received 25 505(q) petitions.

The delayed 505(b)(2) approval was delayed by 28 days. “FDA was concerned that if it approved the 505(b)(2) application before resolving the issues raised in the petition and later concluded that one or more of the arguments against approval were meritorious, then the presence on the market of a drug product that did not meet the requirements for approval could negatively affect public health,” says FDA in the report (in what is now boilerplate language).  FDA does not identify by name or application number the particular approval delayed.

As to the number of 505(q) citizen petitions submitted in FY 2017, the Report says that the Agency received 25 petitions, which is up from 19 in FY 2016. The outcomes of FDA’s 210 petition responses from FY 2008 through FY 2017 are shown in a table included in the report. Approximately 67% (141 petitions) of the 210 petition decisions have been denials, while another approximately 25% (53 petitions) have been denied in part and granted in part.  Only about 5% (10 petitions) have been granted.  Two petitions were granted in FY 2017, which is the first year in which FDA has granted a 505(q) petition since FY 2013.  We think both of those petition decisions concerned the availability of New Chemical Entity exclusivity (see here and here).  The remaining 6 petitions (about 3%) were voluntarily withdrawn by the petitioner.  (You can view all relevant petitions on the FDA Law Blog Citizen Petition Tracker.)

As to 505(q) petitioning trends and FDA concerns, the Agency continues a trend of paring down comments that appeared in previous reports. That being said, FDA’s bottom line in the FY 2017 Report maintains the tone adopted in the FY 2016 report and concludes with the statement, “Accordingly, as part of the Drug Competition Action Plan, FDA is reviewing what actions can be taken to address these issues.”

FDA Commissioner Dr. Scott Gottlieb announced the Agency’s Drug Competition Action Plan (“DCAP”) in Spring 2017 (here).  The intent of the DCAP is to encourage generic drug development and competition.  Since the creation of the DCAP, FDA has taken several steps to implement that plan, including holding a public meeting in July 2017, issuing REMS guidance in May 2018 (here), and issuing last week a Manual of Policies and Procedures on internal FDA responsibilities and procedures for developing a single, shared system REMS or a separate REMS (here).   Given FDA’s statement that the Agency is reviewing what actions can be taken under the DCAP to address citizen petition concerns, more new citizen petition initiatives may be on the horizon.

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And the Nominees Are…. FDA Law Blog’s Top 10 Device Posts of 2018

And the Nominees Are…. FDA Law Blog’s Top 10 Device Posts of 2018

By Rachael E. Hunt

The recent government shutdown gave us some time to reflect on 2018, a year that was full of device-related posts.  Inspired by the recent Academy Awards nominations, we are now listing our Top Ten Device Posts of 2018.  Some are blockbusters, and others indie stories, but they all earned a coveted place in the HPM Top Ten.  Accompanied by a brief explanation for why they made the list, they are:

  1. Multiple Function Device Products – FDA Clarifies Its Approach (May 8, 2018)

The draft guidance indicates that FDA will not regulate functions of a multi-function product that do not meet the statutory device definition or are devices that are subject to an existing enforcement discretion policy.  Although issued in the context of medical device software, FDA states that it will apply the same principles to traditional devices as well.

  1. A Future Regulatory Paradigm with Potential Broader Implications (May 29, 2018) (FDA’s Pre-Cert Program)

FDA’s request for feedback on the Software Precertification Program, in which data is leveraged so that FDA can adopt a risk-based, streamlined approach to Software as a Medical Device review.  This could – someday – replace the need for a premarket submission or allow for a streamlined premarket review for higher risk products.

  1. IVD Technical Assistance—2 posts

FDA was asked to provide Technical Assistance regarding the Diagnostic Accuracy and Innovation Act (DAIA), intended to provide a regulatory framework for Laboratory Developed Tests.  FDA advanced a different framework than that set forth in DAIA, one which essentially revamps the regulation of all In Vitro Diagnostics.  These blog posts consider the implications of the proposed changes for industry.  Many of these suggestions were incorporated in revised draft legislation.  (See our recent post on draft IVD legislation here).

  1. FDA Issues Final Rule on Voluntary Malfunction Summary Reporting Program for Device Manufacturers (Sep. 25, 2018)

The Voluntary Malfunction Summary Reporting Program permits manufacturers to report certain device malfunctions for low-risk products in summary form on a quarterly basis, as an alternative to the Medical Device Reporting (MDR) requirements.  This program has several significant limitations, described in detail in the blog post.

  1. Final Guidance Issued for Considering Benefit-Risk Factors in 510(k)s with Different Technological Characteristics (Oct. 5, 2018)

FDA sets forth a framework for analyzing the benefit-risk profile of a new device when determining whether it is as safe and effective as the predicate device in the review of substantial equivalence.  This guidance is intended to improve predictability, consistency and transparency in the 510(k)-review process.

  1. If at First You Don’t Succeed, Try, Try, Try Again: FDA Issues Plan to Increase Efficiency of 510(k) Third Party Review Program (Oct. 12, 2018)

FDA announced a plan for revamping the 510(k) Third Party Review Program, including the issuance of a draft guidance that says it all: “510(k) Third Party Review Program.”  This blog post reviews the current Third Party Review Program, how this new guidance purports to change it, and our assessment of its likelihood of making a difference.

  1. FDA Issues Two New Guidance Documents on Voluntary Consensus Standards, Consolidating and Replacing Earlier Guidance (Oct. 30, 2018)

This post reviews two new guidance documents that consolidate information on voluntary consensus standards used in medical device premarket submissions: (1) a draft guidance titled “Recognition and Withdrawal of Voluntary Consensus Standards”; and (2) a final guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”

  1. Possible Major Changes to 510(k) Program Ahead (Nov. 26, 2018)

This post reviews the implications of an announcement by FDA Commissioner Dr. Scott Gottlieb and Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health, that FDA is planning to “modernize” the 510(k) process through the elimination of old predicates and the creation of an alternative “Safety and Performance Based” 510(k) Pathway.  This new story got a lot of buzz in the broader media.

  1. Failure to File Adverse Event Reports Results in Criminal Pleas for Medical Device Company and Quality Manager (Dec. 12, 2018)

This post outlines a recent example where the government targeted a manufacturer for failure to file adverse event reports associated with its duodenoscope product, rendering the product misbranded.  The plea agreement requires the company to distribute to its U.S. customers a notice about the plea agreement, undertake certain compliance measures specific to MDR processes, and pay a fine of $80 million as well as a $5 million forfeiture.

  1. Comments on FDA’s Proposed Rule Governing the De Novo Classification Process (Dec. 13, 2018)

On December 4, 2018, FDA issued a proposed rule that would govern the de novo classification process.  This post analyzes the implications of the proposed rule, including an assessment of whether it unduly increases the burden on applicants.  Spoiler alert.  We think it does.

Honorable Mention: Draft Guidance Explains how Uncertainty should be Handled in Device Premarket Submissions (Oct. 2, 2018)

This post analyzes FDA’s draft guidance, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions,” which is intended to describe factors that FDA will consider when assessing uncertainty as part of a benefit-risk assessment in PMA, De Novo, and HDE submissions.

In all, 2018 was a year filled with worthy contenders for a Top Ten ranking.  With the shutdown, 2019 is off to a slow start, but there’s plenty of time to catch up.

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HP&M’s Hatch-Waxman Practice Grows With the Addition of Michael Shumsky

HP&M’s Hatch-Waxman Practice Grows With the Addition of Michael Shumsky

Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Michael Shumsky has become its newest Director.  Mike joined HP&M in February 2019 after nearly 15 years at Kirkland & Ellis LLP, where he played a key role in developing that firm’s FDA and pharmaceutical practices.

As a Director at HP&M, Mike will continue to provide strategic advice and counseling to U.S. and global pharmaceutical companies pursuing FDA approval of NDAs, 505(b)(2) products, ANDAs, BLAs and biosimilar applications.  In addition to helping clients develop successful regulatory strategies and perfect high-stakes regulatory submissions, Mike has litigated a number of significant Hatch-Waxman matters arising from the award or denial of 180-day exclusivity, 3-year and 5-year exclusivity, orphan drug exclusivity, 30-month stays, and REMS-related matters.  Courts and commentators alike have praised Mike’s abilities as both a writer and oral advocate, and he repeatedly has been recognized as a “Rising Star” in both the Life Sciences and Appellate Litigation fields.

Mike graduated from Harvard College, where he was elected to Phi Beta Kappa, and Yale Law School, where he was an officer on the Yale Law Journal.  After law school, Mike clerked for the Hon. Diarmuid F. O’Scannlain on the U.S. Court of Appeals for the Ninth Circuit.  He currently serves as a Lecturer in Law at Columbia Law School, where he teaches a popular seminar on the U.S. Supreme Court.

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