The Regulation of Biological Product Manufacturing: An Introduction
A session from FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More
Recorded March 5–6, 2024
The Regulation of Biological Product Manufacturing: An Introduction
Examine requirements for establishment registration and listing. Learn about inspection requirements. Recognize FDA’s inspection authority and its enforcement process.
Seth Olson, Associate, Latham & Watkins LLP
This session was recorded as part of FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Course in March 2024.
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SETH OLSON is an associate in the Washington, D.C. office of Latham & Watkins LLP and a member of the Healthcare & Life Sciences Practice. He advises clients on regulatory, compliance, and transactional matters involving the US Food and Drug Administration (FDA) and other federal health agencies. Mr. Olson’s clients include members of the medical device, pharmaceutical, biotechnology, human cell and tissue product, food, dietary supplement, and cosmetic industries. Mr. Olson advises clients along the total product life cycle of FDA-regulated products, including, among others: Pre-market product development and testing, FDA premarket submissions, Product advertising and promotion, Quality systems, policies and procedure, responding to FDA Warning Letters and Inspection, Internal Quality Investigations, Postmarket compliance and field actions, and Importing/exporting medical products. Within the transactional space, Mr. Olson advises on regulatory diligence and disclosure matters for public offerings, mergers and acquisitions, and private transactions. Mr. Olson previously served as Regulatory Counsel in the Center for Devices and Radiological Health at the Food and Drug Administration.


























































































































