Individual skill
tooluniverse-drug-regulatory
Drug regulatory and approval research — FDA substance registry, ATC/EPC classification, EMA decisions, generic-drug status, FDA Orange Book exclusivity, NDA/BLA pathways. Use for jurisdiction-aware approval status (FDA vs EMA), generic vs brand availability, exclusivity expiry tracking, and regulatory pathway selection. Always specifies the market when reporting status.
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# Drug Regulatory Research
**Regulatory status depends on jurisdiction.** FDA approval does not equal EMA approval — check the specific market the user is asking about. Generic availability depends on BOTH patent expiry AND regulatory approval — a patent may have expired but no ANDA may yet be filed or approved. Exclusivity codes (NCE, ODE, PED) can block generics even after patent expiry; always check `FDA_OrangeBook_get_exclusivity` before concluding a generic can enter. A 505(b)(2) NDA is not a generic — it requires its own clinical data and gets its own exclusivity period.
**LOOK UP DON'T GUESS**: never assume NDA numbers, exclusivity dates, or ATC codes — always call FDAGSRS, Orange Book, and RxClass tools to retrieve current data; regulatory status changes with new approvals and expirations.
Regulatory intelligence for drugs: identify FDA substances, classify drugs by therapeutic
category, check approval and generic status, retrieve label sections, and find clinical trials.
## When to Use
- "What is the FDA regulatory status of semaglutide?"
- "Is there a generic for Humira?"
- "What ATC class does metformin belong to?"