Regulatory Catalysts

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:

{
  "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:

{
  "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:

"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.