Before a new drug is approved, the FDA requires extensive toxicological testing to ensure its safety. The agency reviews data from preclinical studies, which include pharmacological and toxicological evaluations in animals. These studies help determine potential toxic effects and safe dosage levels. If the preclinical data is satisfactory, the drug proceeds to clinical trials, where its safety is further assessed in humans. The FDA continuously monitors the drugâs safety even after approval through post-market surveillance.
