))
Pharma: The last word - Regulatory and legal trends in the pharma and biotech industries
Manage episode 421288172 series 2916794
Innhold levert av Hogan Lovells. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Hogan Lovells eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.player.fm/legal.
In this episode of "Pharma - The last word," host Phil Katz, discusses regulatory and legal trends in the pharma and biotech industries with Komal Karnik Nigam. They delve into the FDA's evolving approach to data packages required for drug approval, highlighting the increased flexibility in accepting alternative forms of evidence. Komal explains how FDA's guidance has shifted from demanding large, multicenter trials to considering confirmatory evidence such as natural history studies, mechanistic data, and data from other products in the same class. The episode emphasizes the importance of strategic planning and early consideration of data presentation in regulatory interactions.
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.
49 episoder
Del
