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Pharma – The Last Word – Breaking Barriers: The FDA’s Evolving Approach to Biosimilars and Interchangeability
Manage episode 441689179 series 2916794
Kandungan disediakan oleh Hogan Lovells. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Hogan Lovells atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.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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52 episod
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