Lexology August 2, 2023
The Food and Drug Administration (FDA) has released a draft guidance titled, “Good Clinical Practice (GCP) E6(R3),” explaining how the Agency plans to apply its regulations to modern clinical trial designs.
The guidance was drafted in collaboration with the International Council for Harmonisation (ICH) to “provide a unified standard to facilitate the mutual acceptance of clinical data for ICH member countries and regions.” It revises a 2018 guidance to provide clarity on FDA’s expectations around clinical trials in order to help encourage more innovative and efficient trial designs. Israeli companies conducting clinical trials in the US should review this guidance to determine how it might impact their work.
GCP harmonization
FDA is a founding member of ICH, dating back to...
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