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……

{ Comments are closed }

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.

{ Comments are closed }

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.

{ Comments are closed }

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.

{ Comments are closed }

Pharmacogenetic Tests: Recent FDA Authorization for One and Warnings about Others

Pharmacogenetic Tests: Recent FDA Authorization for One and Warnings about Others

By Serra J. Schlanger & Jeffrey N. Gibbs

On October 31, 2018, FDA announced that 23andMe could market its Personal Genome Service Pharmacogenetic Reports test (the “23andMe test”) as a direct-to-consumer test for providing information about genetic variants that may be associated with medication metabolism.  The 23andMe test was reviewed using the de novo premarket review pathway.  FDA authorized the 23andMe test to detect 33 variants for multiple genes after finding that the test is accurate and provides reproducible results, and that consumers can understand the test’s instructions and reports.

On November 1, 2018, just one day after authorizing the 23andMe test, FDA issued a safety communication warning patients and health care providers against the use of other genetic tests that claim to predict patient responses to medications.  The safety communication was accompanied by a joint statement from the directors of CDRH and CDER, Dr. Jeffrey Shuren, J.D. and Dr. Janet Woodcock.  FDA’s safety communication applies to tests offered through health care providers, as well as tests advertised directly to consumers.  The safety communication stated that “claims for many genetic tests to predict a patient’s response to specific medications have not been reviewed by FDA, and may not have the scientific or clinical evidence to support this use for most medications.”  FDA also warned genetic testing companies that the agency is looking into test developers who may be inappropriately selling genetic tests for unapproved uses and that the agency “will take compliance actions when appropriate.”

FDA’s safety communication focused on genetic tests that claim to provide information about a patient’s response to medications including predictions about which medication should be used, which medications may be less effective, and which medications may have an increased chance of side effects. FDA raised concerns that health care providers may make inappropriate changes to a patient’s medication based on the results from these genetic tests which may put patients at risk for potentially serious health consequences.  However, FDA also acknowledged that some genetic tests may provide information about patient responses to medication based on evidence that supports a correlation between a genetic variant and drug levels within the body.  FDA stated that medications’ labels may provide general information on how genetic variations may impact medication levels in patients or may describe how genetic information can be used in determining therapeutic treatment.  Drug labeling was the only data source referenced by FDA.

The FDA safety communication did not explicitly mention laboratory-developed tests (LDTs). However, reports generated by laboratories currently provide pharmacogenetic data beyond that which appears in the drug labeling.  FDA has long taken the position that it will exercise enforcement discretion with LDTs.  It is difficult to see any basis for departing from that practice here.

FDA’s statement focuses heavily on the information in drug labels. While that is one important source, it is hardly the only one; there is a significant and growing amount of scientific literature regarding pharmacogenetics.  It appears in the safety communication that FDA is establishing drug labeling as the only currently acceptable source of pharmacogenetic information.  Given the rate at which new pharmacogenetic data are being generated and the lag in updating drug labeling, this approach could lead to clinicians not being given the most current pharmacogenetic information.  It will also be important to watch this area further to see if FDA departs from its standard enforcement discretion approach towards LDTs.

{ Comments are closed }

Is Your 510(k) Device a Combination Product?

Is Your 510(k) Device a Combination Product?

By Adrienne R. Lenz*

Earlier this year, FDA quietly made changes to their 510(k) clearance letters related to combination products cleared via the 510(k) pathway. The letters now include the following language (new text in bold italics):

Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions.

You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

As noted in the second excerpt, the designation of a product as a combination product imposes additional regulatory requirements over those products regulated strictly as medical devices (see our previous blog posts here and here). Therefore, it is something manufacturers want to be aware of to ensure compliance with all applicable regulations.  For this reason, FDA’s identification of combination product clearances is a helpful improvement.

We are, however, surprised that FDA has chosen to communicate this important information, i.e., whether the device is a combination product or not, to sponsors solely through the database and not more formally through the clearance letter itself. Although many sponsors are likely aware of their product’s status as a combination product going into or during a 510(k) submission’s review, there are some products where the designation may not be as obvious.  Manufacturers should also be aware that the database field has been populated for 510(k)s going back as far as 1993.  In a brief review of older 510(k)s marked as a combination product in the database, we found records for products we would not traditionally think of as combination products, such as surgical gowns and drapes, monitoring systems, and defibrillators, which makes us question whether these are unique products or if there might be errors in the database record.  We do not know if FDA has a review step as part of its database updates to ensure all information and links are accurate.  Therefore, it is a good idea for sponsors to review the database carefully to make sure their products’ designations are correct both for new clearances and also for older products that are still marketed.

* Senior Medical Device Regulation Expert

{ Comments are closed }

HP&M Snags Another Award: LMG Life Sciences

HP&M Snags Another Award: LMG Life Sciences

By Hyman, Phelps & McNamara, P.C.

As 2018 winds down, awards season is in full swing! Last week we announced that Hyman, Phelps & McNamara, P.C. (“HP&M”) was tapped by U.S. News and Best Lawyers as the recipient of the 2019 “Law Firm of the Year in FDA Law” award.  This week we learned of yet another award . . . from LMG Life Sciences, which identifies itself as “the definitive guide to leading North American law firms and lawyers specialized in the life sciences industry.”

LMG Life Sciences announced that HP&M has been awarded the “Highly Recommended” badge for both Medical Devices and Pharmaceuticals. In addition, LMG Life Sciences identifies eight HP&M Directors as “Stars,” one of whom (Jeffrey N. Gibbs) was also recently inducted into the LMG Life Sciences Hall of Fame!

{ Comments are closed }

FDA Proposed Rule Allows Waiver of Informed Consent If IRB Finds Risk Is Minimal

FDA Proposed Rule Allows Waiver of Informed Consent If IRB Finds Risk Is Minimal

By Jeffrey K. Shapiro

The informed consent requirements in drug and device trials are important for subject protection. But there are trials where it is not possible (or difficult) to obtain consent, and the risk to subjects is minimal.

Until recently, these trials could not go forward. In the 21st Century Cures Act, Congress stepped in.  Section 3024 amends drug and device provisions in the Federal Food, Drug, and Cosmetic Act that require informed consent for clinical studies to allow a waiver, if the testing poses “no more than minimal risk” to the subjects and/or the investigator and has “appropriate safeguards.” It is left to FDA to fill out the details.

FDA has just announced a proposed rule. As the FDA Commissioner, Scott Gottlieb, M.D., explains:

Over the years, we’ve received feedback from sponsors and investigators that they were not able to move forward in conducting important clinical investigations where there would be minimal risk as these trials involved situations where obtaining informed consent wasn’t possible, and the agency lacked the authority to permit a waiver of informed consent for that research. With the passage of the 21st Century Cures Act, the FDA’s authorities were changed, allowing greater flexibility. That’s why today, we’re proposing a change to our informed consent regulations in a way that maintains safeguards to protect study participants, while allowing important research to proceed where there is minimal risk to patients.

The proposed rule that would defer to institutional review boards (IRBs) to make the waiver decision. To waive informed consent, IRBs must find:

  • The research involves no more than minimal risk to the subjects;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • The research could not practicably be carried out without the waivers or alterations; and
  • Whenever appropriate, the subjects will be provided with additional patient information after participation.

In 2017, FDA issued guidance to similar effect based upon passage of the Cures Act. It will be withdrawn when the newly proposed rule becomes final.  Comments on the proposed rule are due by January 14, 2019.

{ Comments are closed }

Crazy Kind of Claims

Crazy Kind of Claims

By Jennifer M. Thomas

Once in a while a consumer class action catches our particular attention.  Most recently, Kind LLC was sued in the U.S. District Court for the Eastern District of New York over its advertising, labels, and ingredient statements for its “Pressed by KIND” and “KIND Fruit Bites” products.   Readers may remember Kind as the company that took on FDA’s outdated definition of “healthy” and won.  Nevertheless Kind, like others in the food industry, continues to face class action litigation.

The lead plaintiff in this most recent case, Cassandra Song, claims that Kind’s advertising and product labeling falsely conveys that the fruit bar and fruit bites products are “manufactured from whole fruit ingredients,” and leave “a reasonable consumer” with the impression that Kind’s ingredients are (1) “whole . . . at the point directly prior to their transformation” into the products,  (2) “not processed into non-whole form product derivatives and then recombined to form the products,” and (3) “fresher and healthier . . . .”  The Plaintiff also alleges that Kind’s claims of “no added sugar” are false or misleading.

The Song complaint is not the first of its kind.  It closely resembles complaints filed against That’s It Nutrition, LLC and Trader Joe’s Company by the same law firm earlier this year.  Similar to those complaints, the recent complaint against Kind describes the target products’ nutrition labeling and ingredient statement, and conjectures that Kind’s alleged advertising messages cannot be true based on various label factors such as the quantity of Vitamin C in certain products (which allegedly shows that ascorbic acid must have been added), the economics of transporting fresh tropical fruit, the total declared sugar versus the likely sugar content of component ingredients, and the necessary addition of sugars in the course of dehydrating fruit using a process referred to as “dewatering impregnation soaking.”

These types of allegations involving ingredient identity and common and usual names have been met with mixed results in prior court cases.  The That’s It Nutrition and Trader Joe’s Company complaints mentioned above were voluntarily dismissed in July.

Given the potential barriers to the plaintiff’s success in this case (preemption, primary jurisdiction, consumer understanding, and materiality to name a few) and the seemingly speculative nature of some of the allegations, it is unclear whether the Song complaint will progress any further than the two similar actions that preceded it.  The mere filing of this complaint, however, serves as a reminder to companies that plaintiffs in the food space will continue to look back into companies’ processing and ingredient-sourcing to find fodder for false advertising litigation.

{ Comments are closed }

More Kryptonite for Kratom

More Kryptonite for Kratom

By Gugan Kaur & Douglas B. Farquhar

Most people think of getting salt water taffy from resort beach town Myrtle Beach, SC. But, apparently, there is more activity going on in Myrtle Beach: a company there was supplying customers with kratom, a substance that the government contends is an illegal dietary supplement. On November 5, 2018, the U.S. Department of Justice, on behalf of FDA, filed a civil forfeiture complaint pursuant to 21 U.S.C. § 334 in the U.S. District Court for the District of South Carolina to seize a large quantity of kratom products, including finished kratom powder and capsule products labeled as supplements, as well as bulk kratom powder and capsules.

The government’s complaint alleges that there are serious concerns regarding the health impacts of kratom consumption and its potential for abuse. The complaint further alleges that the kratom products are dietary supplements and dietary ingredients within the meaning of the Federal Food, Drug, and Cosmetic Act and are adulterated under 21 U.S.C. § 342(f)(1)(B) because kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury.

This is not the first time the government filed a complaint for forfeiture of kratom products. As noted in a previous post (here), FDA previously issued an import alert targeting kratom (an import alert is easily imposed by FDA without a requirement for judicial authorization).  The recently announced seizure indicates that FDA also intends to go after products already on the domestic market and it is just the most recent of the problems faced by the kratom industry (see our previous posts here and here). This complaint in Myrtle Beach (which also is the home of a Pinball Museum) indicates that kratom products are still very much on the government’s radar.

{ Comments are closed }

HP&M to Co-Host “DEA Compliance During the Opioid Epidemic” Webinar

HP&M to Co-Host “DEA Compliance During the Opioid Epidemic” Webinar

By Kurt R. Karst

Hyman, Phelps & McNamara, P.C. is co-hosting a complimentary webinar, with Five Rivers Rx, on DEA compliance during the current opioid epidemic. The webinar is scheduled for November 15, 2018 (3:00-4:00 PM ET) and is geared especially towards DEA-registered manufacturers, distributors, importers, exporters and practitioners.

The webinar will focus on:

  • The Controlled Substances Act and its implementing regulations;
  • DEA’s response to the opioid abuse epidemic;
  • Controlled suspicious order legal and regulatory requirements;
  • DEA enforcement actions for suspicious order violations;
  • The Masters Pharmaceutical decision;
  • The Support for Patients and Communities Act and
  • Suspicious Order Monitoring Programs.

The webinar will feature HP&M attorneys Karla Palmer and Larry Houck. You can register for the webinar here.  After registering, you will receive a confirmation email containing information about joining the webinar.

{ Comments are closed }

FDA Finalizes One Guidance and Issues a Draft Guidance Related to the Amended Nutrition Labeling Regulations

FDA Finalizes One Guidance and Issues a Draft Guidance Related to the Amended Nutrition Labeling Regulations

By Riëtte van Laack

Last week FDA published a final guidance and a draft guidance related to the nutrition labeling regulation amendments published in 2016.

Final guidance

The Guidance, titled “Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals,” replaces FDA’s January 2017 draft guidance.

The draft guidance prompted more than 1600 comments to FDA. Although the final guidance added some clarification regarding certain aspects, several issues raised in the comments remain unresolved (e.g., the requirement to declare added sugars on single ingredient sources of sugars, such as honey).

The final guidance is 7 pages longer than the draft guidance. As with the draft guidance, the section on added sugars labeling is by far the largest section.  It is also the section with the most changes.  Among others, the final guidance includes 7 additional Q&As on added sugar declaration.  Also, the order of the Q&As has been mixed up, making it difficult to read; some of the answers refer to answers that come later thus requiring a lot of paging back and forth.  The calculations remain complicated and it remains to be seen if this guidance document provides sufficient clarity.  Likely, FDA inspectors and industry will need further education and examples to make sure that the amount of added sugars declared on a product containing fruit juice concentrate is correct.

FDA also corrected some of its rounding criteria for minerals and vitamins. Companies would be well-advised to review the revised table and accompanying text.

Draft guidance

FDA published a long-awaited draft guidance addressing the new requirements related to single-serving containers, and mandatory and voluntary dual-column labeling. As with other nutrition labeling guidance, the draft guidance uses a Q&A format.  Guidance on this subject is needed: the requirements for single serving containers and dual column labeling for packages that contain at least 200 percent and up to and including 300 percent of the applicable reference amount customarily consumed (RACC), e.g., a 75-g bag of chips that is 250 percent of the RACC of 30 grams for chips, constitute a major amendment to the nutrition labeling requirements.

Comments must be submitted by January 4, 2019, to be considered by FDA before it begins work on the final guidance document.   Since the compliance date for companies with annual food sales of 10 million or more is January 1, 2020, FDA is on a tight timeline.

{ Comments are closed }

Recruiting Class of 2018 – HP&M Adds Three New Attorneys and Two Regulatory Professionals

Recruiting Class of 2018 – HP&M Adds Three New Attorneys and Two Regulatory Professionals

By Hyman, Phelps & McNamara, P.C.

It’s been a busy year at Hyman, Phelps & McNamara P.C. as we’ve added three new attorneys and two regulatory professionals to our ranks.  The five professionals collectively add depth and breadth to our practice with FDA and industry experience.

Deborah L. Livornese joined HP&M as Of Counsel to the Firm.  Ms. Livornese has extensive experience in a broad range of FDA regulatory issues, particularly in the pharmaceutical industry.   Prior to joining HP&M, Ms. Livornese spent seven years in the Office of Regulatory Policy in FDA’s Center for Drug Evaluation and Research. As a Senior Regulatory Counsel at FDA, she was involved in a wide variety of policy issues in the areas of drug approvals and withdrawals, the regulation of unapproved and over-the-counter drugs, and opioid drugs, and user fee programs.  Prior to joining FDA, Ms. Livornese was Of Counsel with an FDA boutique law firm in Washington DC where she advised drug companies on promotional activities for compliance with FDA, FTC and HHS  requirements, and assisted clients in responding to investigational findings, warning letters, and inquiries from the FDA and other agencies.

Adrienne R. Lenz joined HP&M as a Senior Medical Device Regulation Expert.  Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters.  Prior to joining the Firm, Ms. Lenz worked as an independent regulatory consultant and consultant with Emergo.  She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical.

Veronique Li joined HP&M as a Senior Medical Device Regulation Expert.  She provides counsel to medical device and in vitro diagnostic (IVD) manufacturers with regard to both premarket and postmarketing issues.   In the premarket area, Ms. Li prepares IDEs, 510(k)s, de novos, and PMAs. She also prepares pre-submissions, and assists clients in preparing for and represents clients at pre-submission meetings with FDA. In the postmarket area, she advises clients on complaint handling, MDRs, field actions, and QSR compliance. Prior to joining HPM, Ms. Li held positions in a medical device company, management consulting firm, and at the FDA in both the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research.

Kalie E. Richardson joined HP&M as an Associate Attorney, focusing her practice on FDA regulatory strategy and compliance, primarily for small to mid-sized pharmaceutical companies.  Ms. Richardson was a French translator before becoming a lawyer with a focus on medical and pharmaceutical texts. Prior to joining the firm, Ms. Richardson practiced food and drug law at another law firm.  During law school, Ms. Richardson worked in the Centers for Disease Control and Prevention, and the Office of Regulatory Policy at the Center for Drug Evaluation and Research at FDA.

McKenzie E. Cato joined HP&M as an Associate Attorney, practicing in all areas of FDA regulatory law. She graduated with honors from the George Washington University Law School this year.  Ms. Cato started at HP&M in 2012 and worked as a Legal Assistant and Law Clerk prior to becoming an Associate Attorney.

{ Comments are closed }

HP&M Takes Home 2019 “Law Firm of the Year in FDA Law” Honors from U.S. News and Best Lawyers

HP&M Takes Home 2019 “Law Firm of the Year in FDA Law” Honors from U.S. News and Best Lawyers

By Hyman, Phelps & McNamara, P.C.

Hyman, Phelps & McNamara, P.C. (“HP&M”) has once again been ranked as a “Tier 1” law firm in the area of “FDA Law” (both nationally and in Washington, D.C.) by the folks over at U.S. News & World Report, who teamed up with Best Lawyers for the 2019 “Best Law Firms” rankings.

Actually, it’s better than that! HP&M was handed the “Law Firm of the Year in FDA Law” award by both organizations!  We’re truly honored.

“This year we reviewed 14,643 law firms throughout the United States – across 75 national practice areas – and a total of 2,118 firms received a national law firm ranking. We are proud that the ‘Best Law Firms’ rankings continue to act as an indicator of excellence throughout the legal industry,” according to U.S. News.  National and metro rankings are based on a rigorous evaluation process.  Evaluators collect client and lawyer evaluations, conduct peer review from leading attorneys in their field, and review additional information provided by law firms.

{ Comments are closed }