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

Aaron L. Josephson  Senior Director, ML Strategies

Benjamin M. Zegarelli Associate, Health Law Practice / FDA Regulatory, Mintz

Elizabeth K. Conti Associate, Health Law Practice / FDA Regulatory, Mintz

NY and CA CLE Credit: Mintz is an approved CLE provider. This webinar is accredited in the following states: California (1.0 general credit) and New York (1.0 credit in the Areas of Professional Practice).