Regulatory Requirements for INDs/FIH (First in Human) Studies

The safety of pharmaceutical agents, medical devices, and food additives is the toxicology issue of the most concern to the public. Chapter 1, Title 21 of the Code of Federal Regulations (21 CFR) govern the testing, manufacture, and sale of pharmaceutical agents in the U.S. This article examines the regulations that establish how the safety of human pharmaceutical products is evaluated and established in the United States and the other major international markets prior to initial trials in human beings. Keywords: human pharmaceutical products; regulations; safety evaluation; toxicity testing