Overview of Biological Products Law and FDA’s Regulatory Processes

A session from FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More

Recorded February 27, 2024

Overview of Biological Products Law and FDA’s Regulatory Processes

Learn about the role of the Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) in the regulation of medical products, including biological products, drugs, and devices. Identify and become familiar with key aspects of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHSA) that authorize FDA to make regulatory decisions, issue regulations and guidances, and develop regulatory policy for medical products, and how stakeholders can participate in these activities. Learn about FDA’s responsibilities under the Freedom of Information Act, and about the Agency’s duty to safeguard confidential commercial information, trade secrets, and other information.

Patrick C. Gallagher, Partner, Duane Morris LLP

This session was recorded as part of FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More in March 2024. 

Get Access

$149
  • +$100 for nonmembers

Internet Explorer and Microsoft Edge are not supported by the checkout process.

Please use Chrome, Firefox, or Safari.  If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.

Virtual Learning FAQ

On-demand webinar content is sent via email as soon as we are able to process and verify your order. This usually occurs within 1 business day.

 

On-demand content can be played back on most devices.

 

CLE credit is not currently available for pre-recorded sessions.

Related Content