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.

Steven S. Tjoe, Partner, Goodwin Procter LLP
Elizabeth Mulkey, Associate, Goodwin Procter LLP

This session was recorded as part of FDLI’s Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Course in October 2023. 


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