The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice
FDA Law Blog
FEBRUARY 27, 2025
While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). Implications for Future of Clinical Research R3 represents an important evolution in GCP, shifting away from a prescriptive model toward a more flexible, risk-based approach.
Let's personalize your content