Articles & Newsletters
- Contract Pharma, April 20, 2020
- Law360, April 2, 2020
- Lexis Practice Advisor Journal, April 1, 2020
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.
Webinar Recording
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
Bioequivalence Studies
Bioequivalence Studies for Submission in ANDAs during the COVID-19 Pandemic
Clinical Electronic Thermometers
Compounding of Certain Drugs for Hospitalized Patients
Developing Drugs and Biological Products
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
Diagnostic Tests
Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency
Digital Health Devices For Treating Psychiatric Disorders
Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices
Face Masks
General Considerations for Pre-IND
Gowns
Hand Sanitizers
Infusion Pumps and Accessories
Non-Invasive Fetal and Maternal Monitoring Devices
Non-Invasive Remote Monitoring
Prescription Drug Samples
Remote Digital Pathology Devices
Remote Ophthalmic Assessment and Monitoring Devices
Sponsors Requesting EUAs
Ventilators
Select COVID-19 Resources