FDA in the Time of COVID-19
Date: April 14, 2020
Time: 1:00PM - 2:00PM (EST)
Location: View the Webinar Recording
Join Mintz and ML Strategies for the next installment in our webinar series. This session will explore the full spectrum of FDA-related legal issues facing companies in the life sciences, medtech, and digital health industries during this complicated period.
The program will cover the following topics:
FDA accommodations and measures to help drug, biologic, and device companies respond to the COVID-19 pandemic
• Emergency Use Authorizations (EUAs) and enforcement discretion policies
• Coronavirus Treatment Acceleration Program (CTAP)
• Expanded access to investigational treatments
New policies impacting existing product sponsors
• Relief from certain ongoing postmarketing obligations
• Updated regulatory policies on reporting medical product shortages
Enforcement climate for COVID-19 related products
Looking ahead
• Status of legislative priorities like the VALID Act, Cures 2.0, and user fee reauthorization
• Business as usual at FDA in unusual times
Speakers
