FDA approval
Authorisation by the US Food and Drug Administration to market a drug for a specific indication.
FDA approval is the regulatory authorisation by the US Food and Drug Administration to market a drug for a specific indication. It typically follows phase 3 clinical trial completion and requires a New Drug Application (NDA) submission with full pharmacology, toxicology, manufacturing, and trial data. Approved status differs from research-grade or compounded status — only approved formulations carry FDA-monitored quality controls and post-marketing surveillance. Research peptides on the omegagrade.com catalogue range from FDA-approved (tesamorelin, semaglutide, tirzepatide) to phase-3 investigational (retatrutide, cagrilintide) to research-only with no clinical development (BPC-157, MOTS-c).
- GlossaryPhase 3
The penultimate stage of clinical drug development — large randomised trials testing efficacy and safety against existing standards of care.
- GlossaryPharmacokinetics
How the body absorbs, distributes, metabolises, and eliminates a compound — "what the body does to the drug."
- GlossaryPharmacodynamics
"What the drug does to the body" — the relationship between concentration and effect.