FDA (Food and Drug Administration)
The United States federal agency responsible for regulating drugs, biological products, medical devices, and food safety. FDA approval is one of the most influential regulatory benchmarks globally and is one of three jurisdictions tracked by PeptideTrace for compound regulatory status.
Technical Context
Key FDA centres for peptide drugs: CDER (Center for Drug Evaluation and Research) reviews NDAs for most synthetic peptides; CBER (Center for Biologics Evaluation and Research) reviews BLAs for biological peptide products. The FDA's review divisions specialise by therapeutic area — peptide drugs may be reviewed by the Division of Diabetes, Lipid Disorders, and Obesity (GLP-1 RAs), Division of Oncology (proteasome inhibitors, radiopharmaceuticals), Division of Reproductive and Urologic Products (GnRH compounds), or other divisions. FDA regulatory science initiatives relevant to peptides include: guidance on peptide drug product manufacturing, biosimilar development pathways, and real-world evidence frameworks. The FDA inspects manufacturing facilities worldwide for GMP compliance and can issue warning letters, import alerts, and consent decrees for violations.