# Regulatory Catalysts [Health: Active]

**Category:** 🧬 Biology & Bioinformatics  
**Repository:** https://github.com/pipeworx-io/mcp-regulatory-catalysts  
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**Directory Page:** https://allmcps.com/mcp/regulatory-catalysts

## Description
Regulatory Catalysts MCP — high-value biotech regulatory calendar events (keyless).

## Tools
Capabilities this server exposes over MCP:

- **fda_adcom_calendar** — Upcoming FDA advisory committee (AdCom) meeting calendar — a leading biotech regulatory catalyst. Lists FDA panel meetings announced in the Federal Register (keyless), extracting the scheduled meeting date from each notice. Covers oncology (ODAC), cellular/tissue & gene therapy (CTGTAC), and every other FDA advisory committee; captures panel-vote meetings that precede or accompany drug/biologic approval decisions (PDUFA-adjacent). Returns each meeting with committee, meeting date (ISO when parseable) plus raw date text, topic, publication date, Federal Register URL, and document number, sorted soonest-first. Use for AdCom, advisory committee, panel vote, drug approval catalyst, FDA meeting calendar, upcoming biotech panels.
- **pdufa_catalysts** — Companies with disclosed PDUFA dates — the highest-signal binary biotech catalyst. Searches recent SEC EDGAR 8-K filings (keyless) for PDUFA target / goal / action dates and extracts the date and surrounding context. A PDUFA date is the FDA decision date for an NDA or BLA; it is a scheduled binary event that moves biotech stocks. Returns each disclosure with company, ticker, CIK, filing date, form, PDUFA date (ISO when the filing gives a specific day), pdufa_period when the filing discloses only a coarser grain such as "Q1 2027" or "March 2027", a short context snippet, the SEC filing URL, and accession number. A row may carry a period without a date — that is the filing being vague, not a lookup failure. Use for PDUFA date, PDUFA goal date, FDA decision date, upcoming FDA decisions, drug approval catalyst, NDA/BLA decision date, biotech binary event, catalyst by ticker. ALSO the REGULATORY-STATUS reading of the same data, which is what most callers actually ask: which drugs are currently UNDER FDA REVIEW, which medicines ENTERED FDA REVIEW or were ACCEPTED FOR REVIEW recently, new NDA/BLA SUBMISSIONS and FILINGS ACCEPTED by the FDA, drugs AWAITING FDA APPROVAL, what is in the FDA review queue. A company announces acceptance in an 8-K at the moment review begins, so filing_date is when the drug ENTERED review and pdufa_date is when the decision is due — bounding filing_date with since/until answers "what entered FDA review last week". Note this is REGULATORY review of a marketing application, not clinical trials: for drugs entering or moving through TRIALS use the clinicaltrials tools instead.
- **fda_adcom_materials** — What evidence is an FDA advisory committee reviewing? For one FDA advisory committee (AdCom) meeting — picked by committee (ODAC, VRBPAC, CTGTAC, or any name fragment), by date, and/or by drug, sponsor or topic — returns the meeting page's posted materials: FDA and sponsor briefing documents, the agenda, questions to the committee, rosters, presentation slides, minutes and transcripts, each with a document type, party (FDA / sponsor / combined), file type and size, and URL. Also extracts the agenda text, the applications under review (NDA/BLA number, product, sponsor, proposed indication), the public docket number, the webcast link, and — when a Questions document is posted — the VOTING QUESTIONS text itself. Reads FDA's own advisory-committee calendar (fda.gov, keyless), which lists meetings from 2016 to the next scheduled one; when a meeting has nothing posted yet it says so with the meeting date and FDA's posting timeline instead of returning an empty list. Use for AdCom briefing document, FDA briefing book, advisory committee materials, ODAC questions, what is the panel voting on, sponsor briefing package, panel agenda, FDA presentation slides, AdCom transcript or minutes. Pair with fda_adcom_calendar (which meetings are coming) and pdufa_catalysts (the decision date that follows the panel).

## Claude Desktop Quick Installation
Install path detected from listing signals. Uses `npx` (confidence: high):

```json
"mcpServers": {
  "regulatory-catalysts": {
    "command": "npx",
    "args": ["-y","@pipeworx/mcp-regulatory-catalysts"]
  }
}
```

## Documentation

## What Regulatory Catalysts does

Regulatory Catalysts provides MCP access to three biotech regulatory research tools. It covers FDA advisory-committee schedules, the public materials attached to those meetings, and PDUFA dates disclosed by companies in SEC filings.

The service is useful when an agent needs to answer questions such as which FDA panels are meeting soon, what a committee will review, which sponsors or applications appear on an agenda, or when an FDA decision is expected. It is an unofficial integration and is not affiliated with, endorsed by, or published by the FDA or SEC.

## How it works

The hosted MCP endpoint is available at `https://gateway.pipeworx.io/regulatory-catalysts/mcp`. A client can also connect to the full Pipeworx gateway at `https://gateway.pipeworx.io/mcp`; both routes use the same gateway and data sources. The scoped endpoint lists the pack's tools along with shared Pipeworx meta-tools, unless the local npm bridge is used without `PIPEWORX_META_TOOLS=1`.

The calendar tool reads the FDA advisory-committee calendar data. Meeting-material searches use FDA calendar and meeting pages, including linked PDFs. PDUFA searches use full-text SEC EDGAR searches across 8-K filings. Calls require network access; the npm package does not provide an offline mode.

For advisory-committee material lookups, filters can use a committee acronym or name fragment, a full or partial date, and a drug, sponsor, application, or topic query. Query matching checks meeting titles first, then Federal Register notices, and finally the text of nearby meeting pages. Results can identify how the match was found.

## Setup and configuration

A hosted MCP client can use this configuration:

```json
{
  "mcpServers": {
    "regulatory-catalysts": {
      "url": "https://gateway.pipeworx.io/regulatory-catalysts/mcp"
    }
  }
}
```

Claude Desktop, Cursor, and Windsurf are shown as supported client examples. The tools can also be called through the gateway's HTTP API, such as `POST https://gateway.pipeworx.io/v1/tools/fda_adcom_calendar` with a JSON request body.

For local stdio use, run the package through `npx`:

```json
{
  "mcpServers": {
    "regulatory-catalysts": {
      "command": "npx",
      "args": ["-y", "@pipeworx/mcp-regulatory-catalysts"]
    }
  }
}
```

Anonymous use is capped at 50 calls per day. Adding a Pipeworx account key raises the limit to 200 calls per day:

```json
"env": { "PIPEWORX_API_KEY": "<your key>" }
```

Set `PIPEWORX_META_TOOLS=1` when the local bridge should also list shared tools such as `ask_pipeworx`, `discover_tools`, `search_within`, and memory tools. Behind an HTTPS proxy, newer Node.js versions may require `NODE_USE_ENV_PROXY=1` for the built-in `fetch` implementation to honor proxy settings.

## Tools and capabilities

- `fda_adcom_calendar` lists scheduled FDA advisory-committee meetings announced in the Federal Register and extracts meeting dates.
- `fda_adcom_materials` returns meeting metadata, agenda text, parsed applications, public docket details, webcast links, and posted materials such as briefing documents, presentations, minutes, transcripts, rosters, and questions.
- `pdufa_catalysts` searches recent SEC EDGAR 8-K filings for disclosed PDUFA target, goal, or action dates and returns surrounding filing context.

Material results can include voting-question text and flags identifying numbered questions. The service distinguishes meetings with no materials posted from an empty search result and reports upstream failures as errors rather than silently returning an empty list.

## Limitations and notes

FDA does not provide per-document posting dates or structured vote tallies through the meeting pages used here. The service returns the page's content-current date as `materials_as_of`; vote results remain in linked minutes and transcripts. The questions-PDF extraction step is best effort, so an extraction error can appear alongside the document URL while the rest of the meeting response remains available.

The npm bridge forwards requests to the hosted gateway and therefore needs internet access. Anonymous calls have a daily limit, and authenticated calls are metered and billed in the same way as hosted connections. Shared Pipeworx meta-tools are included on the hosted pack endpoint, which can make its listed tool count larger than the three pack-specific tools.

_Full upstream README: https://allmcps.com/mcp/regulatory-catalysts/readme_