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M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Draft Guidance for Industry; Draft Template; and Technical Specification; Availability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
| Type | Title | Status |
|---|---|---|
Notice |
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Draft Guidance for Industry; Draft Template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