JD Supra

Clinical Trial Protocol Deviations: A New FDA Draft Guidance to Ring in the New Year

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
JD Supra

FDA draft clinical trial guidance promotes decentralized studies, digital tech use - GCP guidance comes ahead of FDA DCT webinar

Last week, the U.S. Food and Drug Administration (FDA) issued draft guidance on Good Clinical Practice (GCP), adopting the International Council for Harmonisation’s (ICH) “E6(R3)” guidelines. Below we ...
Labroots

Highlights of the In Vitro Sections of the Draft ICH Drug Interaction Studies M12 Guideline and Comparison with Current Guidance

In June 2022, the ICH released the first draft of its harmonized global Drug Interaction Studies Guideline (M12). The guideline is the result of several meetings of the Expert Working Group since 2018 ...