fda-analystlisted

# fda-analyst A skill for analyzing FDA novel drug approvals. Powered by the [trove project](https://github.com/cbetz/trove)'s curated index of recent FDA approvals plus the actual approval-package documents on accessdata.fda.gov. ## When to use this skill Invoke when the user asks about: - **A specific FDA-approved drug** — what was the basis for approval, what trials supported it, what endpoints were used. - **Adverse events the FDA flagged** at approval (read from the medical review, not the label). - **Regulatory pathway** — was it accelerated approval, breakthrough, priority review, fast track. - **Approval-document content** — anything in the medical review, statistical review, pharmacology review, chemistry review. - **Cross-drug comparisons** along regulatory dimensions. ## Don't use this skill for - **Clinical advice or dosing.** This is a reference tool over public approval documents, not a substitute for the prescribing label or clinical judgment. - **Drugs approved before 2021.** The current trove index covers 2021–2024 only. Earlier drugs aren't in the published bundle yet. - **Devices, biosimilars, generics, or supplemental approvals.** Out of scope. Vaccines and blood products are also out of scope — trove ingests only the CBER cell & gene therapy page, not the broader CBER vaccines/blood list. - **Devices, biosimilars, or generic (ANDA) approvals.** Out of scope — the trove index covers FDA's curated "Novel Drug Approvals" lists (NMEs and novel BLAs)