15 min

Highlights from FDA Regulatory Developments in Clinical Trials: 2023 Recap and 2024 Forecast K&L Gates Health Care Triage

    • Business

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.

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.

15 min

Top Podcasts In Business

développement personnel
Wachem
Yomi Denzel
Yomi Denzel
Strong Girl Boss
Mathilde WOD
Le OV Show
Olivier Vullierme
C'est Juste une question de temps
Podcast Investir Au Pays
The Diary Of A CEO with Steven Bartlett
DOAC