Episode 106 – The FDA's New Playbook: Biosimilars, National Priority Vouchers, and the Plausible Mechanism Pathway
About this episode
The episode discusses recent FDA actions affecting drug and biologic development, including new programs and guidance.
Recent FDA actions are reshaping key aspects of drug and biologic development, including the Commissioner's National Priority Voucher program, the "plausible mechanism" pathway for personalized therapies, and new draft guidance aimed at streamlining biosimilars and interchangeables. Join Washington, D.C. partner Nathan Beaton and counsel Monica Groat and Chad Jennings as they discuss how these moves differ from traditional policy-making, as well as the practical implications for pricing, manufacturing, M&A, and litigation risk in the healthcare and life sciences industry. This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your…
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