How does the FDA evaluate the toxicity of a new drug?
The FDA assesses new drugs through a rigorous process that includes preclinical and clinical trials. Preclinical testing involves animal studies to identify toxicological endpoints such as carcinogenicity, reproductive toxicity, and organ toxicity. Once preclinical data suggest that a drug is safe, it proceeds to clinical trials, which are conducted in phases to further evaluate safety, efficacy, and dosing in humans. The FDA reviews these data before granting approval for public use.
