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Highlights from FDA Regulatory Developments in Clinical Trials: 2023 Recap and 2024 Forecast

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Manage episode 404839551 series 1533910
Indhold leveret af K&L Gates LLP and L Gates. Alt podcastindhold inklusive episoder, grafik og podcastbeskrivelser uploades og leveres direkte af K&L Gates LLP and L Gates eller deres podcastplatformspartner. Hvis du mener, at nogen bruger dit ophavsretligt beskyttede værk uden din tilladelse, kan du følge processen beskrevet her https://da.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.

  continue reading

100 episoder

Artwork
iconDel
 
Manage episode 404839551 series 1533910
Indhold leveret af K&L Gates LLP and L Gates. Alt podcastindhold inklusive episoder, grafik og podcastbeskrivelser uploades og leveres direkte af K&L Gates LLP and L Gates eller deres podcastplatformspartner. Hvis du mener, at nogen bruger dit ophavsretligt beskyttede værk uden din tilladelse, kan du følge processen beskrevet her https://da.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.

  continue reading

100 episoder

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