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FDA in the Time of COVID-19

Apr
14
2020

Date: April 14, 2020

Time: 1:00PM - 2:00PM

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 S. Hawana counsels global Mintz clients on regulatory and distribution-related considerations for new FDA-regulated products. She also advises clients on the business impacts of new federal and state actions on food, drugs, cosmetics, electronic nicotine systems, and medical devices.
Aaron L. Josephson is a Senior Director of ML Strategies who advises clients on health care policy issues related to medical devices and pharmaceuticals. Earlier, he was with the US Food and Drug Administration, including as a senior policy advisor in the Center for Devices and Radiological Health.
Benjamin M. Zegarelli is a Mintz Associate who counsels clients on compliance and regulatory issues, with a focus on FDA regulations. Benjamin advises clients in the pharmaceutical, medical device, and biotech industries. He provides counsel on research approval, sales, and contract negotiations.
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.