FDA drug approvals, 510(k) device clearances, recalls and adverse-event reports.
Connect FDA Approvals to Claude, Cursor or any other MCP client and it stops being a tab you switch to. FDA drug approvals, 510(k) device clearances, recalls and adverse-event reports. The fda approvals mcp server is what makes that connection.
Hosted MCP server over openFDA. Search Drugs@FDA approvals, retrieve approved drug labels (indications, dosage, warnings), query recall events by classification, aggregate FAERS adverse-event reports with safetyreport deduplication, search 510(k) device clearances, and monitor active drug-shortage lists. For pharma research, clinical decision support, and regulatory LLMs.
Because this one is hosted, setup is mostly authentication — you point your client at the endpoint and approve access. Nothing runs on your machine, so there is no runtime to keep patched.
The toolset is worth reading before you wire it up, because it tells you what the integration is really for:
fda_drug_approval_search — sponsor?, brand?, generic?, date_from?, date_to?, limit?fda_drug_label — namefda_recall_search — classification?, date_from?, date_to?, limit?fda_adverse_events — drug, limit?fda_510k_search — query?, applicant?, limit? — Team+fda_drug_shortages — limit? — Team+Plenty of developer tooling servers cover similar ground. The differences that matter in practice are scope of access and how much setup stands between you and a working tool call. FDA Approvals's toolset — fda_drug_approval_search, fda_drug_label, fda_recall_search and 3 more — is a fair guide to whether it matches your workflow. It is maintained by guptaprakhariitr; worth a glance at recent repository activity before you build anything load-bearing on it.
We check each listing at SyncDev against the project's documentation before it goes live — if something here drifts out of date, it is a bug worth reporting.
| Tool | What it does |
|---|---|
| fda_drug_approval_search | sponsor?, brand?, generic?, date_from?, date_to?, limit? |
| fda_drug_label | name |
| fda_recall_search | classification?, date_from?, date_to?, limit? |
| fda_adverse_events | drug, limit? |
| fda_510k_search | query?, applicant?, limit? — Team+ |
| fda_drug_shortages | limit? — Team+ |
Or wire it into your MCP client:
```jsonc
{
"mcpServers": {
"fda-approvals": {
"command": "npx",
"args": ["-y", "@insnapsprakhar/fda-approvals-mcp"]
}
}
}Configuration as documented by the project. Restart the client after saving.
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