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:

Terminal

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:

Terminal

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": { } }
  }'

Tools exposed

Tool	Arguments	Description
`fda_drug_approval_search`	`sponsor?, brand?, generic?, date_from?, date_to?, limit?`	Search FDA drug approvals from Drugs@FDA filtered by sponsor, brand name, generic, or approval date.
`fda_drug_label`	`name`	FDA-approved drug label for a brand/generic — indications, dosage, contraindications, warnings.
`fda_recall_search`	`classification?, date_from?, date_to?, limit?`	Search drug/device/food recall events by Class I/II/III and date.
`fda_adverse_events`	`drug, limit?`	Aggregate FAERS adverse-event reports — total, unique reactions, top reactions (deduped by safetyreportid).
`fda_510k_search`	`query?, applicant?, limit? — Team+`	Search FDA 510(k) medical-device clearances.
`fda_drug_shortages`	`limit? — Team+`	Current FDA-tracked drug-shortage list.

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:

Terminal

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:

config.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):

config.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"
      ]
    }
  }
}

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

Getting an API key

Visit https://fda-approvals-mcp.atlasword.workers.dev/upgrade?tier=solo (or tier=team / tier=pro).
Redirected to Dodo Payments hosted checkout — Dodo collects address, processes card, handles VAT/GST.
After payment, Dodo fires a signed webhook (subscription.active) to the Worker. The Worker mints mck_<32 random base64url> and stores it in KV.
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).
Paste the key into Cursor / Claude Desktop config (see above).
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

Route	Description
`POST /mcp`	MCP JSON-RPC 2.0 tool surface (the main API). Bearer auth required for paid tiers.
`GET /health`	Liveness probe — `{ok: true, ts}`. Used by mcp-hub cron.
`GET /`	HTML landing page (OG + favicon + JSON-LD).
`GET /upgrade?tier=solo	team
`GET /welcome?key=...`	Post-checkout landing showing the freshly-minted API key.
`GET /account`	Bearer-auth. Returns `{apiKey, tier, owner, status, portal_url}`.
`POST /account/rotate`	Bearer-auth. Mints a fresh key + retires the old one.
`GET /account/export`	Bearer-auth. GDPR data export — JSON of account, usage counters, Dodo details.
`GET /account/team`	Bearer-auth (Team+). List team-member sub-keys.
`POST /account/team/invite`	Bearer-auth (Team+). Issue a new team-member sub-key.
`POST /account/team/revoke`	Bearer-auth (Team+). Revoke a team-member sub-key.
`GET /team/accept?key=...`	Team-member onboarding landing for the sub-key URL.
`POST /webhooks/dodo`	Standard-Webhooks signed. Dodo subscription + payment lifecycle.
`GET /favicon.ico`	Inline SVG.

Pricing

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

Tier	Monthly calls	Rate limit	Team seats
Free	100 / month	10 / minute	0
Solo	2,000 / month	60 / minute	0
Team	10,000 / month	200 / minute	5
Pro	50,000 / month	600 / minute	25

Plan	Price	Monthly calls	Team seats
Free	$0	100	0
Solo	$9/mo	2,000	0
Team	$29/mo	10,000	5
Pro	$79/mo	50,000	25

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:

Terminal

npx -y @insnapsprakhar/fda-approvals-mcp

Or wire it into your MCP client:

JSON Config

{
  "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).