tooluniverse-drug-regulatory

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?"
• "Get adverse reactions from the ibuprofen drug label"
• "When does the patent for Eliquis expire?"
• "List all drugs in the ACE inhibitor class"
• "Find clinical trials for a biosimilar of adalimumab"

NOT for (use other skills instead)

• Drug-drug interactions -> Use tooluniverse-drug-drug-interaction
• Pharmacogenomics / dosing by genotype -> Use tooluniverse-pharmacogenomics
• Drug mechanism of action / target binding -> Use tooluniverse-drug-mechanism-research
• Drug repurposing / new indications -> Use tooluniverse-drug-repurposing

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Workflow Overview

Input (drug name / brand name / UNII)
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Phase 1: Substance Identification  -- FDAGSRS_search_substances, FDAGSRS_get_substance
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Phase 2: Drug Classification       -- RxClass_get_drug_classes, RxClass_find_classes
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Phase 3: Approval & Generic Status -- FDA_OrangeBook_search_drug, FDA_OrangeBook_check_generic_availability
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Phase 4: Patent & Exclusivity      -- FDA_OrangeBook_get_patent_info, FDA_OrangeBook_get_exclusivity
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Phase 5: Label Parsing             -- DailyMed_parse_adverse_reactions, DailyMed_parse_dosing, etc.
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Phase 6: Clinical Trials           -- search_clinical_trials
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Phase 7: Pharmacovigilance         -- FAERS_count_reactions_by_drug_event (param: medicinalproduct)
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Phase 8: Literature & Approval     -- PubMed_search_articles, OpenFDA_get_approval_history, RxNorm_get_drug_names