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Pharma – The Last Word – Breaking Barriers: The FDA’s Evolving Approach to Biosimilars and Interchangeability
Manage episode 441689179 series 2916794
Hogan Lovells에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Hogan Lovells 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
In this episode, host Phil Katz sits down with Deborah Cho, to discuss the evolving landscape of biosimilarity and interchangeability. They dive into the FDA's changing approach, highlighting the shift towards treating biosimilars and interchangeable biosimilars as a single category. Deborah explains how advancements in technology and experience have reduced the need for additional studies, and why the FDA is pushing for a statutory change to streamline approvals.
The future episodes will focus on specific areas of the law, such as drug development, clinical trials, FDA compliance, and more, providing listeners with a detailed look at the complexities of pharmaceutical regulations and practical strategies for navigating them.
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