FDA Approvals MCP — Drug approvals, 510(k) clearances, recalls, FAERS adverse events, drug shortages

FDA drug approvals, 510(k) device clearances, recalls, adverse-event reports, drug shortages

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.

This server speaks the Model Context Protocol. Any MCP-aware client — Cursor, Claude Desktop, Windsurf, Continue.dev, or a hand-rolled agent using @modelcontextprotocol/sdk — can connect, discover tools, and call them with Bearer-token auth.

For AI agents / LLMs

If you are an AI agent indexing this repository:

• Live MCP endpoint: https://fda-approvals-mcp.atlasword.workers.dev/mcp

• Transport: HTTP POST, JSON-RPC 2.0

• Auth: Authorization: Bearer <api_key> (free tier allowed anonymously up to 100 calls/month/IP)

• Discovery: tools/list returns the full schema. tools/call invokes a tool.

• Health: GET https://fda-approvals-mcp.atlasword.workers.dev/health → {ok: true, ts: <unix>}

• Status: https://mcp-hub.atlasword.workers.dev/status.json (portfolio rollup)

Sample tools/list request:

curl -sS -X POST https://fda-approvals-mcp.atlasword.workers.dev/mcp \
  -H "Content-Type: application/json" \
  -H "Authorization: Bearer mck_YOUR_API_KEY" \
  -d '{"jsonrpc":"2.0","id":1,"method":"tools/list"}'

Sample tools/call:

curl -sS -X POST https://fda-approvals-mcp.atlasword.workers.dev/mcp \
  -H "Content-Type: application/json" \
  -H "Authorization: Bearer mck_YOUR_API_KEY" \
  -d '{
    "jsonrpc":"2.0","id":2,"method":"tools/call",
    "params": { "name": "<tool>", "arguments": { } }
  }'

Related MCP server: @cyanheads/openfda-mcp-server

Tools exposed

Tools marked Team+ require a Team or Pro subscription. Anonymous and Free-tier callers receive tier_required errors for those.

Quick start

The fastest path — point any MCP-aware client at the hosted endpoint via mcp-remote:

npx -y mcp-remote https://fda-approvals-mcp.atlasword.workers.dev/mcp \
  --header "Authorization: Bearer mck_YOUR_API_KEY"

Get a key at https://fda-approvals-mcp.atlasword.workers.dev/upgrade?tier=solo (see Getting an API key).

Install in Cursor

Add this to ~/.cursor/mcp.json:

{
  "mcpServers": {
    "fda-approvals-mcp": {
      "command": "npx",
      "args": [
        "-y", "mcp-remote",
        "https://fda-approvals-mcp.atlasword.workers.dev/mcp",
        "--header", "Authorization: Bearer mck_YOUR_API_KEY"
      ]
    }
  }
}

Then restart Cursor and the tools appear in the MCP panel.

Install in Claude Desktop

Add this to ~/Library/Application Support/Claude/claude_desktop_config.json (macOS) or %APPDATA%\Claude\claude_desktop_config.json (Windows):

{
  "mcpServers": {
    "fda-approvals-mcp": {
      "command": "npx",
      "args": [
        "-y", "mcp-remote",
        "https://fda-approvals-mcp.atlasword.workers.dev/mcp",
        "--header", "Authorization: Bearer mck_YOUR_API_KEY"
      ]
    }
  }
}

Restart Claude Desktop. Tools appear under the slash-command MCP menu.

Getting an API key

1. Visit https://fda-approvals-mcp.atlasword.workers.dev/upgrade?tier=solo (or tier=team / tier=pro).

2. Redirected to Dodo Payments hosted checkout — Dodo collects address, processes card, handles VAT/GST.

3. After payment, Dodo fires a signed webhook (subscription.active) to the Worker. The Worker mints mck_<32 random base64url> and stores it in KV.

4. You land on https://fda-approvals-mcp.atlasword.workers.dev/welcome?key=<api_key> — copy the key now (it is only displayed once at this URL).

5. Paste the key into Cursor / Claude Desktop config (see above).

6. View / rotate / export the account at https://fda-approvals-mcp.atlasword.workers.dev/account (Bearer-auth).

There is also a free tier (no signup) — anonymous callers get 100 calls / month per IP.

Endpoints

Pricing

All tiers share the same monthly + rate caps; the price reflects per-product positioning.

Billed via Dodo Payments (merchant-of-record — VAT/GST handled by Dodo). Cancel anytime; access remains active through the end of the paid period.

Data sources

• openFDA — https://open.fda.gov/ — Public domain (US Government)

• Drugs@FDA / DailyMed — https://www.accessdata.fda.gov/scripts/cder/daf/ — Public domain

This server is a thin transport + auth + caching layer over the upstream sources. Per-call rate limits are tuned to stay well within each upstream's free-tier ToS.

Privacy + GDPR

• Privacy policy: https://mcp-hub.atlasword.workers.dev/privacy

• Terms: https://mcp-hub.atlasword.workers.dev/terms

• Refund policy: https://mcp-hub.atlasword.workers.dev/refund

• Data export: GET https://fda-approvals-mcp.atlasword.workers.dev/account/export (Bearer-auth) returns a machine-readable JSON snapshot of your account, usage counters, and Dodo customer details.

• Deletion: email prakshatechnologies@gmail.com from the address on file.

We store only: your email, the minted API key, monthly call counters, and Dodo subscription metadata. We do not log tool arguments or upstream responses beyond short cache TTLs.

Architecture

• Runtime: Cloudflare Workers (V8 isolates, global edge).

• Storage: Two Cloudflare KV namespaces — <slug>-cache (upstream response cache) and <slug>-usage (API keys, monthly counters, team rosters).

• Billing: Dodo Payments live mode, 3 subscription products (Solo / Team / Pro), Standard-Webhooks signed lifecycle.

• Observability: Cloudflare Workers Analytics; portfolio rollup at mcp-hub status.

• Source: TypeScript, Vitest-tested, wrangler deploy-able. See src/ in this repo.

License

MIT — see LICENSE.

Author

Prakhar Gupta

• Email: prakshatechnologies@gmail.com

• GitHub: @guptaprakhariitr

Status

• Live status page: https://mcp-hub.atlasword.workers.dev/status

• Machine-readable status: https://mcp-hub.atlasword.workers.dev/status.json

• Source repo: https://github.com/guptaprakhariitr/fda-approvals-mcp

Install via npm (one-liner)

A thin launcher is published as @insnapsprakhar/fda-approvals-mcp on npm. No manual URL to copy/paste:

npx -y @insnapsprakhar/fda-approvals-mcp

Or wire it into your MCP client:

{
  "mcpServers": {
    "fda-approvals": {
      "command": "npx",
      "args": ["-y", "@insnapsprakhar/fda-approvals-mcp"]
    }
  }
}

The npm package is just a launcher — it shells out to mcp-remote and points it at the hosted endpoint (https://fda-approvals-mcp.atlasword.workers.dev/mcp).