))
Pharma – The Last Word – Breaking Barriers: The FDA’s Evolving Approach to Biosimilars and Interchangeability
Manage episode 441689179 series 2916794
Inhalt bereitgestellt von Hogan Lovells. Alle Podcast-Inhalte, einschließlich Episoden, Grafiken und Podcast-Beschreibungen, werden direkt von Hogan Lovells oder seinem Podcast-Plattformpartner hochgeladen und bereitgestellt. Wenn Sie glauben, dass jemand Ihr urheberrechtlich geschütztes Werk ohne Ihre Erlaubnis nutzt, können Sie dem hier beschriebenen Verfahren folgen https://de.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.
You can find additional thought leadership and information regarding digital health on Engage.
If you are interested in more information about Life Sciences and Health Care, follow us via LinkedIn and Twitter.
52 Episoden
Teilen
