U.S. Food and Drug Administration — the U.S. regulator for food, drugs, biologics, devices, and cosmetics.
FDA approval is granted via the NDA pathway (for small molecules) or BLA pathway (for biologics, including most peptides). Peptidepedia uses FDA status alongside EMA status as the two primary regulatory authority signals for every compound.
Compounds where this term is relevant
- Semaglutide · GLP-1 receptor agonist · once-weekly subcutaneous
- Tirzepatide · Dual GIP / GLP-1 receptor agonist · once-weekly subcutaneous
- Tesamorelin · Synthetic GHRH analogue · stimulates pituitary GH release · daily subcutaneous
- Bremelanotide · Melanocortin (MC1R/MC3R/MC4R) receptor agonist · on-demand subcutaneous
Related terms
- EMA · European Medicines Agency — the EU regulator responsible for the centralized aut…
- INN · International Nonproprietary Name — the unique generic name assigned to a pharma…
- Prescription-only · A regulatory status requiring a valid prescription from a licensed healthcare pr…
- 503A compounding · A U.S. regulatory category permitting state-licensed pharmacies to compound cust…