FDA-Regulated Research

FDA-Regulated Research

Under the terms of UAB's FWA, research involving human subjects is reviewed in accordance with HHS regulations (45 CFR Part 46) and any other applicable regulations, laws, and policies. When the FDA has oversight of the research, FDA regulations (CFR Title 21) must be followed in addition to the HHS regulations.

This section of the guidebook contains many of the requirements that investigators, sponsors, and IRBs must fulfill in the conduct and review of FDA-regulated research. However, investigators on such studies should become familiar with the regulations as published (Code of Federal Regulations through Government Printing Office).

Investigational Drugs or Biologics: Investigational New Drug (IND)

Devices (IDE, HUD)

Emergency Use of FDA-Regulated Test Articles

FDA Audits

 

Page updated: May 8, 2013