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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


Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.
Benjamin advises pharmaceutical, medical device and biotech companies on the FDA regulatory process to identify the correct regulatory pathway, assisting with FDA communications and strategy.