A month ago, we blogged on FDA’s emerging strategy of granting Emergency Use Authorizations (EUAs) for devices, drugs, and biologics that can be used to combat the spread of COVID‑19. Since then, FDA has begun granting EUAs, with more in the pipeline. In addition, the Secretary of Health and Human Services (HHS) has now issued a so‑called PREP Act declaration that triggers extremely robust product liability protection for medical products used pursuant to an EUA.
To help industry understand FDA’s legal tools and role in fighting the pandemic, the Food and Drug Law Institute (FDLI) is hosting a webinar on March 19 (Thursday). It will be free to members and available for a low price to non‑members. Hyman, Phelps & McNamara, P.C.’s Jeff Shapiro will be moderating the panel. Here is FDLI’s description of the webinar:
FDA is actively working with companies to identify potential shortages and mitigate any impacts as early as possible. FDA has also recently approved several Emergency Use Authorizations (EUAs) for medical products used to diagnose or prevent transmission of COVID-19. What is FDA’s role in responding to public health emergencies such as COVID-19? What is FDA’s process for issuing drug, device, or biologics EUAs? What other tools does the agency have to decrease the impact of supply chain disruptions, product shortages, and disease outbreaks, and what are the legal limits to FDA’s authority? How does FDA work with other agencies and entities such as the Centers for Disease Control and Prevention and World Health Organization?
FDA is urgently seeking to authorize diagnostic tests (see this guidance just issued) but it is also approving EUAs for prevention devices (e.g., facial respirators) and, hopefully, there will be vaccines and drug therapeutics that qualify in the near future.
Come join us to learn about EUAs, the PREP Act and more!