Complimentary Webinar
FDA's "Radical Transparency" Initiative and the Release of Complete Response Letters and Related Product Reviews – What We’ve Learned
Date: Wednesday, September 9th, 2026
Time: 1:00 PM EST
FDA’s 2025 decision to publicly release Complete Response Letters (CRLs) marks a significant shift in regulatory transparency and has sparked intense debate across the pharmaceutical and biotechnology industries. As a recent Citizen Petition challenges the Agency’s authority to disclose these communications, companies are left navigating new risks, opportunities, and unanswered questions.
Join us for an insightful webinar, presented by Kurt Karst, as he explores the FDA’s radical transparency initiative, the implications for sponsors and competitors alike, evolving Freedom of Information Act (FOIA) practices, and what legal and regulatory developments may lie ahead. Gain practical insights into how this unprecedented change could impact your regulatory strategy and competitive landscape.
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Speakers
Kurt R. Karst
Director, Hyman, Phelps & McNamara, P.C.
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity. As the co-founder and primary author of Hyman, Phelps & McNamara’s FDA Law Blog, Mr. Karst often leads the response to new rules and regulations, sharing his interpretation with the broader legal community.
Mr. Karst’s knowledge of FDA precedents and timely analysis of developments helps clarify and shape the industry’s understanding of Hatch-Waxman, in particular. He is a prolific writer, contributing to the blog and publishing articles in major legal journals. Mr. Karst has co-authored and contributed to several text books, including Generic and Innovator Drugs: A Guide to FDA Approval Requirements; Pharmaceutical, Biotechnology, and Chemical Inventions; Fundamentals of US Regulatory Affairs; and FDLI’s Drug and Biologic Approvals: The Complete Guide for Small Businesses-FDA Financial Assistance and Incentives.
Mr. Karst clerked for Hyman Phelps & McNamara while attending law school and served as articles editor for the American University Law Review. Before joining the firm, Mr. Karst lobbied for F. Hoffmann-La Roche Inc. In 1995, he was awarded a Fulbright Scholarship for post-graduate studies in Germany.
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