Yesterday, the Agency published it notification on the release of the final version of ICH E6(R3) Good Clinical Practice (GCP) guidance. From the announcement page, it highlights some important updates:
- Increasing flexibility to support a broad range of modern trial designs, data sources, and technology.
- Advancing quality by design and risk-based quality management in trial conduct and oversight.
- Clarifying sponsor and investigator responsibilities.
- Promoting proportionality, relevance, and critical thinking throughout the clinical trial lifecycle.
#fda #ICH #GCP #E6(R3)
Guidance for Industry
| U.S. Food and Drug Administration |
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| Guidance for Industry |
| The Food and Drug Administration is announcing the availability of a final guidance for industry entitled "E6(R3) Good Clinical Practice." This revision incorporates flexible, risk-based approaches and embraces innovations in trial design, conduct, and technology. |
| View this on U.S. Food and Drug Administration > |
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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