July 5, 2020

Volume X, Number 187

July 03, 2020

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Workshop On Bioanalysis To Be Held By FDA

On June 30, 2020, from 9:00 a.m. to 5:30 p.m. (EDT), the U.S. Food and Drug Administration (FDA) will host a free regulatory training for industry on bioanalysis requirements and expectations. Focused on how FDA’s Center for Drug Evaluation and Research (CDER) approaches various issues in bioanalysis, the workshop aims to provide participants with a better understanding of how FDA performs bioanalysis. Topics to be covered, among others, include:

  • Bioanalytical method validation: history, process, and regulatory perspectives;

  • Biosimilars;

  • Regulated bioanalysis for large molecules;

  • Regulated bioanalysis for small molecules;

  • Drugs and biologics;

  • Bioanalysis of unstable analysis;

  • Repeat analysis; and

  • A case study on bioanalytical approaches to mitigate issues identified during bioequivalence clinical site inspection.

Registration is required.

©2020 Bergeson & Campbell, P.C.National Law Review, Volume X, Number 157

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

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