Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry; Availability | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2023-D-5016

Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry; Availability

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensDec 30, 2024

Comment Period ClosesMar 1, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Guidance for Industry - Draft Guidance	Dec 30, 2024	55

Comment Statistics

Total Comments

Keywords

CDER

2019-664

Protocol Deviations for Clinical

Investigations of Drugs, Biological

Products, and Devices; Draft

Guidance for Industry; Availability

OPEN

Data from Regulations.gov