E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-D-1797

E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability

Documents

Comments

Description

Open

Key Dates

Comment Period OpensJul 21, 2025

Comment Period ClosesSep 20, 2025

Documents

Type	Title	Posted	Comments	Status
Other	E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry	Jul 21, 2025	29

Comment Statistics

Total Comments

Keywords

CDER

FRDTS #2023-830

E21 Inclusion of Pregnant and

Breastfeeding Women in Clinical Trials

International Council for Harmonisation

Draft Guidance for Industry; Availability

Open

Data from Regulations.gov