regulatory-intelligence

name	regulatory-intelligence
description	Regulatory intelligence for biopharma due diligence and strategy. Covers FDA/EMA approvals, regulatory pathways, advisory committees, PDUFA dates, breakthrough/fast track designations, and biosimilar/generic entry. Use when users ask about regulatory status, approval timelines, FDA filings, regulatory strategy, or agency interactions.
user-invocable	false

Regulatory Intelligence

Track and analyze regulatory activities for biopharma assets and therapeutic areas.

Data Sources

Gosset MCP Tools

• find_drugs(query, limit, effort) — Drug approval status, regulatory phase
• find_trials(query, limit) — Registrational trials and their status
• find_companies(query, limit) — Company regulatory track record
• gosset_agent(prompt) — Deep research on regulatory history and strategy

openFDA API (Free, no key required for basic use)

Query FDA regulatory data directly via https://api.fda.gov/. Key endpoints:

import requests

# Drug adverse events
r = requests.get("https://api.fda.gov/drug/event.json", params={
    "search": "patient.drug.medicinalproduct:pembrolizumab",
    "limit": 10
})

# Drug labeling (prescribing information)
r = requests.get("https://api.fda.gov/drug/label.json", params={
    "search": 'openfda.brand_name:"Keytruda"',
    "limit": 1
})

# Drugs@FDA (approval history since 1939)
r = requests.get("https://api.fda.gov/drug/drugsfda.json", params={
    "search": 'openfda.brand_name:"Keytruda"',
    "limit": 5
})

# Drug recalls / enforcement
r = requests.get("https://api.fda.gov/drug/enforcement.json", params={
    "search": "reason_for_recall:pembrolizumab",
    "limit": 10
})

# Device 510(k) clearances
r = requests.get("https://api.fda.gov/device/510k.json", params={
    "search": "applicant:Medtronic",
    "limit": 10
})

# Device PMA approvals
r = requests.get("https://api.fda.gov/device/pma.json", params={
    "search": "advisory_committee_description:Cardiovascular",
    "limit": 10
})

Rate limits: 240 req/min without key, 120K/day with free key from https://open.fda.gov/apis/authentication/

ClinicalTrials.gov API (Free)

# Search trials via v2 API
r = requests.get("https://clinicaltrials.gov/api/v2/studies", params={
    "query.term": "pembrolizumab NSCLC",
    "filter.overallStatus": "COMPLETED",
    "pageSize": 20
})

Web Search (supplementary)

• FDA.gov — Approval letters, advisory committee materials, PDUFA dates
• EMA.europa.eu — CHMP opinions, EPARs, marketing authorizations
• FDA Orange Book — Patent and exclusivity listings
• FDA Purple Book — Biosimilar reference products

When to Use

• Due diligence on regulatory risk for an asset
• Tracking PDUFA dates and regulatory milestones
• Analyzing regulatory precedent in an indication
• Evaluating regulatory pathway options
• Monitoring advisory committee outcomes
• Assessing biosimilar/generic entry timing

Workflow

Step 1: Gather Regulatory Data

Asset Regulatory Profile:

find_drugs(query="[drug name]", limit=5, effort="high")
gosset_agent(prompt="What is the complete regulatory history for [drug name]? Include filing dates, approval dates, label expansions, CRLs, advisory committees, breakthrough/fast track designations, and REMS requirements.")

Indication Regulatory Landscape:

find_drugs(query="[indication] approved", limit=50, effort="high")
gosset_agent(prompt="What are the FDA-approved drugs for [indication]? What endpoints and trial designs led to approval? What regulatory precedents exist?")

Step 2: Regulatory Analysis

Approval Pathway Assessment:

Pathway	Criteria	Timeline Impact
Standard NDA/BLA	Full review	10-12 months
Priority Review	Significant improvement	6 months
Accelerated Approval	Surrogate endpoint	Earlier filing, confirmatory trial needed
Breakthrough Therapy	Substantial improvement	Rolling review, intensive guidance
Fast Track	Serious condition, unmet need	Rolling review
RMAT (cell/gene)	Regenerative medicine	Priority review, accelerated approval
Orphan Drug	<200K patients	7 years exclusivity, tax credits
505(b)(2)	Known active ingredient	Reduced data package

Key Regulatory Risks:

• Complete Response Letter (CRL) history in the indication
• Advisory committee voting patterns
• Post-marketing requirements and REMS
• Label restrictions (black box warnings, REMS)
• Manufacturing/CMC issues

Step 3: Regulatory Timeline

Build a regulatory milestone timeline:

Date	Milestone	Status	Impact
[date]	IND filing	Complete	Cleared
[date]	Breakthrough designation	Granted/Denied	Accelerated path
[date]	NDA/BLA submission	Planned/Filed	Under review
[date]	PDUFA date	[date]	Binary event
[date]	Advisory committee	Scheduled	Sentiment signal
[date]	EU MAA	Planned	Ex-US access

Step 4: Report

1. Executive Summary — Regulatory status, key risks, expected timeline
2. Regulatory History — Complete timeline of regulatory interactions
3. Pathway Analysis — Which pathway, why, and precedents
4. Regulatory Risk Assessment — Key risks with mitigation strategies
5. Competitive Regulatory Context — How competitors' regulatory paths compare
6. Recommendations — Regulatory strategy implications for the deal/program