FDA Seeks Public Comment on International Clinical Protocol Standard
June 10, 2025
June 10, 2025
WASHINGTON, June 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a notice published in the Federal Register entitled "M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol" and a supplemental document entitled "M11 Template".
These documents, prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, establi . . .
These documents, prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, establi . . .