FDA Approvals MCP Server

by guptaprakhariitr Your server? Claim it

not responding

FDA Approvals is listed as active in the registry but did not answer our last check. It exposes 4 tools. Last commit 11 Jun 2026.

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

Uptime history 48 days of history · worst day 3%

48 days agonow

3.3%

Uptime 24h

3 of 91 checks

Tools

read from the server

262 ms

Response time

average over 24h

Stars

last commit 11 Jun 2026

FDA Approvals does not always answer

Over the last week it answered 3.4% of our checks. We check every 15 minutes, so you hear about the next outage within the hour — not from your users.

Connect this server

Endpoint below is the one we actually reach during checks — not the one copied from a README. Last verified 12 min ago.

Claude Code Claude Desktop Codex Cursor VS Code

run in your terminal

claude mcp add fda-approvals-mcp --transport http https://fda-approvals-mcp.atlasword.workers.dev/mcp

~/Library/Application Support/Claude/claude_desktop_config.json

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

~/.codex/config.toml

[mcp_servers.fda-approvals-mcp]
url = "https://fda-approvals-mcp.atlasword.workers.dev/mcp"

.cursor/mcp.json

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

.vscode/mcp.json

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

Available tools 4

Read directly from the server with tools/list, grouped by what they act on. If a tool disappears, we record the date.

fda

fda_adverse_events

Aggregate FDA adverse-event reports (FAERS) for a drug. Deduplicates by safetyreportid (bug fixed in 0.2.1). Returns total reports, unique reaction count, and top 20 reactions by frequency in the requested window.

fda_drug_approval_search

Search FDA drug approvals from Drugs@FDA. Filter by sponsor, brand name, generic name, or approval date range. Returns the application number, sponsor, brand/generic name, and approval date for each approval (NDA / BLA / supplemental).

fda_drug_label

Fetch the FDA-approved drug label for a brand or generic name. Includes indications, dosage, contraindications, warnings, adverse reactions.

fda_recall_search

Search drug, device, or food recall events. Filter by classification (Class I = most serious) and date range. Returns recall number, classification, reason, recalling firm, status.

Endpoints

URL	Transport	State	Latency	Checked
https://fda-approvals-mcp.atlasword.workers.dev/mcp	streamable-http	answering	149 ms	12 min ago

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FDA Approvals — questions

Answers built from our own checks of this server.

What can FDA Approvals do?

It exposes 4 tools, read directly from the server on our last check. Among them: fda_adverse_events, fda_drug_approval_search, fda_drug_label, fda_recall_search. The full list with descriptions is on this page — we take it from the server itself via tools/list, not from a README. How MCP servers expose tools in the first place →

Is FDA Approvals working right now?

We send a real MCP handshake every 15 minutes. Over the last 24 hours 3 of 91 checks got a reply (3.3%), average response time 262 ms. The bar chart above shows every period we have measured.

The registry lists FDA Approvals as active — why does it not respond?

The official MCP registry stores what the author submitted; it does not verify that the server still runs. We check the endpoint ourselves, and this one does not answer. Catalogues that copy the registry without checking will show it as working.

How do I connect FDA Approvals?

Copy the ready config from this page — we generate it for Claude Code, Claude Desktop, Codex, Cursor and VS Code, each with the file path that client actually reads. It is a remote server, so there is nothing to install — the client connects to the address.

Does FDA Approvals need an API key?

No. FDA Approvals completed a full MCP handshake with us as an anonymous client and listed its tools without asking for anything. All 4 of them are readable on this page. This is what we observed, not what the docs claim.

How fast is FDA Approvals?

It answers our handshake in 262 ms on average, which is faster than 56% of all working MCP servers we measure. The comparison comes from our own checks across the whole registry, every 15 minutes.

Is FDA Approvals open source?

We cannot say either way: written in TypeScript and 1 stars on GitHub, but we could not determine the licence, and without one the code is not open source by default.