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Current Regulatory Trends Around Extractable and Leachable (E&L) Testing: What We Are Hearing from the FDA

Do you know when to perform E&L testing for an FDA submission? How do you know that the testing you have done or are planning to do will meet the FDA’s strict requirements? In this presentation, Matt Jorgensen, PhD, discusses the concepts of E&L testing. He also discusses the most recent FDA feedback and direction around the testing. Watch the presentation to learn more.

Matthew Jorgensen

Matthew Jorgensen

PhD, DABT
Chemistry and Materials Scientist

Dr. Jorgensen is an expert in chemistry and materials science. He has over a decade of experience designing, synthesizing, and analyzing complex materials. His analytical chemistry background includes research in organic chemistry synthesizing and analyzing a naturally occurring anti-cancer drug, computational treatment of photothermal spectroscopy, and professionally in a commercial lab. Most of his materials...