In the midst of new and unique challenges, many companies are redoubling their development efforts and retooling their manufacturing in response to the COVID-19 pandemic. The Food & Drug Administration (FDA) has responded by rapidly authorizing diagnostics and products through the Emergency Use Authorization process and by providing guidances that seek to expand the availability of certain in-demand medical products, including personal protective equipment, disinfectants, hand sanitizers, diagnostics and medical devices.

Axinn has developed this COVID-19 FDA Resources page to provide relevant articles and other resources, including a complimentary webinar hosted by the Food and Drug Law Institute focused on FDA’s guidances regarding the development of certain medical products. If you have any questions regarding any of these materials or any other FDA issues, please reach out to Chad A. Landmon at clandmon@axinn.com or Matthew S. Murphy at mmurphy@axinn.com.

FDLI Webinar, FDA’s Recent COVID-19 Guidances Facilitating Expanded Access to Certain Medical Products, April 14, 2020

American Bar Association SciTech Brief – Short Video
COVID-19: FDA Emergency Use Authorizations

Select FDA Guidances