Pharmacokinetics, Pharmacodynamics, & Drug Metabolism Community

FDA sent notification of 1 new final guidance and 3 draft guidance on 27Dec24 with publication dates of 30Dec24.  However, 3 are available immediately; with the third having a bad URL.

Final

·        ICH E11A Pediatric Extrapolation https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e11a-pediatric-extrapolation?utm_medium=email&utm_source=govdelivery

Draft:

• ·       ICH E6(R3) Good Clinical Practice: Annex 2 (published link is bad on 27Dec24. Will correct this note when FDA makes its correction. )

• ICH M15 General Principles for Model-Informed Drug Development  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m15-general-principles-model-informed-drug-development?utm_medium=email&utm_source=govdelivery
• Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices   https://www.fda.gov/regulatory-information/search-fda-guidance-documents/protocol-deviations-clinical-investigations-drugs-biological-products-and-devices?utm_medium=email&utm_source=govdelivery

#fda #ICH #M15 #E11A  #E6_R3_Annex2 #ClinicalProtocolDeviations

------------------------------
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>
------------------------------
</bioanalysisandbiomarkers.blogspot.com>