All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2022-D-3054
M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Draft Guidance for Industry; Draft Template; and Technical Specification; Availability
Documents
11
Comments
28
Description
OPEN
Key Dates
Comment Period OpensDec 22, 2022
Comment Period ClosesJul 8, 2025
Documents
Comment Statistics
Total Comments
28
Keywords
CDER
M11 Clinical Electronic Structured
Harmonised Protocol (CeSHarP);
International Council for Harmonisation
Draft Guidance for Industry; Draft Template
and Technical Specification; Availability
OPEN
Data from Regulations.gov