FDA Approvals

io.github.guptaprakhariitrv0.3.1更新於 Oct 7, 2026

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

已驗證Streamable HTTP可網頁執行Data & AnalyticsKnowledge & Memory

概覽

AI 產生的概覽

讓助理查詢 FDA 藥品核准、藥品標籤、召回、不良事件報告、510(k) 許可與藥品短缺資訊。

功能
這是一個託管型 MCP 伺服器，包裝 openFDA 與 Drugs@FDA 資料。工具可依申請廠商、品牌、學名或日期檢索藥品核准；取得核准藥品標籤（適應症、劑量、警告）；依 I/II/III 類與日期檢索召回事件；依 safetyreportid 去重彙總 FAERS 不良事件報告；檢索 510(k) 醫療器材許可；以及查看目前藥品短缺清單。它只是公開 FDA 資料來源的傳輸、驗證與快取層。
適用情境
適合製藥研究、法規或臨床支援類問題，以及需要查詢 FDA 核准、標籤、召回或不良事件資訊、又不想自行串接 openFDA 的助理。
執行需求
遠端 streamable HTTP 端點，不需本機執行環境。付費層級可選用 Authorization Bearer API 金鑰標頭；匿名免費層級每 IP 每月 100 次呼叫。需要網路連線。部分工具（510(k) 檢索、藥品短缺）需要 Team 或 Pro 訂閱。
安裝前請注意
付費層級透過第三方結帳（Solo、Team、Pro 訂閱）計費，安裝可能涉及付費。API 金鑰僅在註冊時顯示一次，並以 Authorization Bearer 標頭傳遞，應視為機密。帳戶端點可輪換金鑰並管理團隊子金鑰。說明稱除短快取 TTL 外不記錄工具參數與回應，但查詢會傳送至第三方託管服務。

安裝

在 SourceWeft 中

  1. 開啟 儀表板中的 FDA Approvals，將其新增到工作區。
  2. 為需要使用其工具的對話啟用該服務。

Web executable，透過 Streamable HTTP。 遠端服務在工作區中設定後即可從網頁執行環境執行。

其他 MCP 客戶端

把它新增到你客戶端的 mcpServers 設定中。

{
  "mcpServers": {
    "fda-approvals-mcp": {
      "type": "http",
      "url": "https://fda-approvals-mcp.atlasword.workers.dev/mcp"
    }
  }
}

README

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

[MIT License] [MCP] [Cloudflare Workers] [Live]

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:

bash
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:

bash
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

ToolArgumentsDescription
fda_drug_approval_searchsponsor?, 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_labelnameFDA-approved drug label for a brand/generic — indications, dosage, contraindications, warnings.
fda_recall_searchclassification?, date_from?, date_to?, limit?Search drug/device/food recall events by Class I/II/III and date.
fda_adverse_eventsdrug, limit?Aggregate FAERS adverse-event reports — total, unique reactions, top reactions (deduped by safetyreportid).
fda_510k_searchquery?, applicant?, limit? — Team+Search FDA 510(k) medical-device clearances.
fda_drug_shortageslimit? — 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:

bash
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:

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):

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

  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

RouteDescription
POST /mcpMCP JSON-RPC 2.0 tool surface (the main API). Bearer auth required for paid tiers.
GET /healthLiveness probe — {ok: true, ts}. Used by mcp-hub cron.
GET /HTML landing page (OG + favicon + JSON-LD).
`GET /upgrade?tier=soloteam
GET /welcome?key=...Post-checkout landing showing the freshly-minted API key.
GET /accountBearer-auth. Returns {apiKey, tier, owner, status, portal_url}.
POST /account/rotateBearer-auth. Mints a fresh key + retires the old one.
GET /account/exportBearer-auth. GDPR data export — JSON of account, usage counters, Dodo details.
GET /account/teamBearer-auth (Team+). List team-member sub-keys.
POST /account/team/inviteBearer-auth (Team+). Issue a new team-member sub-key.
POST /account/team/revokeBearer-auth (Team+). Revoke a team-member sub-key.
GET /team/accept?key=...Team-member onboarding landing for the sub-key URL.
POST /webhooks/dodoStandard-Webhooks signed. Dodo subscription + payment lifecycle.
GET /favicon.icoInline SVG.

Pricing

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

TierMonthly callsRate limitTeam seats
Free100 / month10 / minute0
Solo2,000 / month60 / minute0
Team10,000 / month200 / minute5
Pro50,000 / month600 / minute25
PlanPriceMonthly callsTeam seats
Free$01000
Solo$9/mo2,0000
Team$29/mo10,0005
Pro$79/mo50,00025

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

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

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

Status

Install via npm (one-liner)

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

bash
npx -y @insnapsprakhar/fda-approvals-mcp

Or wire it into your MCP client:

jsonc
{  "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).

來源：README.md，提交 73940ca

工具

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版本歷史

1
  1. v0.3.1最新Sep 16, 2026