Summary of Federal Laws

 

Research

 

Federal Food, Drug and Cosmetic Act

 

21 U.S.C. § 301 et seq.; 21 C.F.R. § 50.1, § 56.101, § 312.1, § 600.3 et seq., and § 812.1 et seq.; 61 Fed. Reg. 51,498 (Oct. 2, 1996)

 

This law applies to research on any product under its regulatory purview.  The protection of human subjects is covered in 21 C.F.R. Parts 50 and 56.  An exception from informed consent requirements for emergency research was added in October 1996, effective November 1, 1996.  See 21 C.F.R. § 50.24.

 

The Office for Good Clinical Practices (OGCP) was established on Oct. 26, 2001 to improve the conduct/oversight of clinical research governed by FDA, and to ensure protection of human subjects. See "Mission" for more on the oversight of this office.

 

21 CFR Part 58 contains the Good Laboratory Practice for Nonclinical Laboratory Studies. These regulations prescribe good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products.

 

Resources

 

Understanding Good Laboratory Practices (Case Western University) This is a Power Point on 21 CFR Part 58, enforced by the FDA. This power point covers good lab practices for conducting nonclinical studies that support applications for research or marketing permits for products regulated by the FDA.

 

FDA Information Sheet Guidances for IRBS, Clinical Investigators, and Sponsors: Includes link to related regulations.

 

Laws enforced by the FDA and related statutes: Includes links to laws and related resources.

 

 

 

links updated 3/12/09 rab; checked 3/14/09 mlo