The Federal Food, Drug, and Cosmetic Act and Public Health Service Act require that sponsors of FDA-regulated products submit evidence of their product’s safety in research and/or marketing applications. These products include food and color additives, animal drugs, human drugs and biological products, human medical devices, diagnostic products, and electronic products. FDA uses the data to answer questions regarding:
- The toxicity profile of the test article.
- The observed no adverse effect dose level in the test system.
- The risks associated with clinical studies involving humans or animals.
- The potential teratogenic, carcinogenic, or other adverse effects of the test article.
- The level of use that can be approved.
The following resources are provided to help investigators, sponsors, and contract research organizations who conduct nonclinical studies on investigational new drugs to comply with U.S. law and regulations covering good laboratory practice (GLP).
- Bioresearch Monitoring: Good Laboratory Practice
- Regulatory Pharmacology and Toxicology
- Toxicological Principles for the Safety of Food Ingredients (Redbook 2000)
- Code of Federal Regulations: Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58)