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FDA in the Time of COVID-19

Apr
14
2020

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

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.
Elizabeth Conti is a Mintz attorney who focuses her practice on regulatory compliance and enforcement defense matters for health care, life sciences, and consumer product companies.