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Highlights from FDA Regulatory Developments in Clinical Trials: 2023 Recap and 2024 Forecast
Manage episode 404839551 series 1533910
Content provided by K&L Gates LLP and L Gates. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by K&L Gates LLP and L Gates or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
In this episode, Rebecca Schaefer, Michael Hinckle, and Elisabeth Lewis summarize FDA regulatory developments from 2023 and what to expect in 2024 as it relates to clinical research. They discuss the significance of the decentralized clinical trials guidance documents, highlights of the Informed Consent Guidance document, the impacts of FDA’s final rule on IRB waivers of consent, the IRB review of individual patient expanded access submissions, and the potential effects of the new proposed rule for lab developed tests.
100 episodes
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Manage episode 404839551 series 1533910
Content provided by K&L Gates LLP and L Gates. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by K&L Gates LLP and L Gates or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
In this episode, Rebecca Schaefer, Michael Hinckle, and Elisabeth Lewis summarize FDA regulatory developments from 2023 and what to expect in 2024 as it relates to clinical research. They discuss the significance of the decentralized clinical trials guidance documents, highlights of the Informed Consent Guidance document, the impacts of FDA’s final rule on IRB waivers of consent, the IRB review of individual patient expanded access submissions, and the potential effects of the new proposed rule for lab developed tests.
100 episodes
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Similar to K&L Gates Health Care Triage
A bootstrappers podcast for founders, entrepreneurs, visionaries and dreamers who are building businesses from the ground up without the taking on debt or selling equity. Here we cover marketing, sales, organization and mindset issues that matter to you
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continue reading
Call them changemakers. Call them rule breakers. We call them Redefiners. And in this provocative podcast, we explore how daring leaders from across industries and around the globe are redefining their organizations—and themselves—to create extraordinary impact in today’s rapidly changing world. In each episode, Russell Reynolds Associates Leadership Advisor Hoda Tahoun and former CEO Clarke Murphy host engaging, purposeful conversations with leaders in and out of the business world who shar ...
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…
continue reading
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