Forward to: Regulatory Affairs

Regulatory Approval Tracking
Workflows

Ten agent workflows for Regulatory Affairs — FDA/EMA submission tracking, advisory committee monitoring, label expansion intelligence, global regulatory pathway analysis, accelerated approval tracking, post-marketing requirement monitoring, regulatory guidance changes, CMC supplement tracking, orphan drug designation intelligence, and regulatory strategy dashboard — enabling data-driven regulatory decisions powered by domain intelligence.

1FDA/EMA Submission Tracker

AI agent monitors pharma and biotech company domains for regulatory submission announcements, PDUFA dates, EMA validation confirmations, and filing acceptance notices.

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Track Global Regulatory Submissions
/investors/press/complianceCountries
REGULATORY SUBMISSION TRACKER — GLOBAL ════════════════════════════════════════════════════════ FDA — UPCOMING PDUFA DATES: pfizer.com — RSV Maternal Vaccine: May 14, 2026 regeneron.com — Dupixent (COPD): Jun 28, 2026 vertexpharm.com — VX-548 (Pain): Aug 12, 2026 EMA — CHMP OPINIONS EXPECTED: novartis.com — Kisqali adjuvant breast: Q2 2026 astrazeneca.com — Datopotamab (NSCLC): Q3 2026 SUBMISSION PIPELINE: FDA filings expected next 6 months: 22 EMA filings expected: 18 PMDA (Japan) filings: 12

2Advisory Committee Monitor

AI agent tracks FDA advisory committee meeting schedules, briefing documents, voting outcomes, and panel composition to predict regulatory decision outcomes.

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Track AdCom Proceedings
/compliance/investors/pressOpenPageRank
ADVISORY COMMITTEE TRACKER ════════════════════════════════════════════════════════ UPCOMING ADCOM — March 15, 2026: lilly.com — Donanemab (Alzheimer's) Panel: Peripheral and Central Nervous System Drugs FDA briefing: Questions on ARIA management Analyst consensus: Favorable vote expected (12-3) SIGNAL: 80% probability favorable outcome RECENT ADCOM RESULTS: intercept.com — OCA (NASH): 8-4 against (benefit-risk) sarepta.com — Elevidys confirm.: 12-2 favorable CORRELATION: AdCom favorable → FDA approval: 92% historically AdCom unfavorable → FDA approval: 28% historically

3Label Expansion Intelligence

AI agent monitors supplemental applications and label update signals across pharma domains to track indication expansions, line-of-therapy changes, and population extensions.

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Track Label Expansion Pipeline
/products/investors/pressIAB Categories
LABEL EXPANSION TRACKER ════════════════════════════════════════════════════════ merck.com — Keytruda Expansion Portfolio /products: 40+ approved indications /investors: 8 additional sBLAs pending /press: Perioperative NSCLC data positive SIGNAL: Most expansive label in oncology history argenx.com — Vyvgart Platform /products: gMG approved | CIDP under review /investors: 5 additional indications in development SIGNAL: FcRn platform expanding across autoimmune INDUSTRY TRENDS: sBLA submissions (2025): 180+ filings Average time to label expansion: 3.2 years post-initial approval

4Global Regulatory Pathway Analysis

AI agent maps global regulatory strategies by monitoring company filings across FDA, EMA, PMDA, NMPA, and other regulatory authorities to identify market access timing and strategy differences.

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Map Global Regulatory Strategies
/compliance/press/aboutCountries
GLOBAL REGULATORY PATHWAY MAP ════════════════════════════════════════════════════════ novartis.com — Kisqali (adjuvant breast cancer) FDA: Approved Feb 2025 EMA: CHMP positive opinion — approved PMDA: Filed Q4 2025 — under review NMPA: Filed Q1 2026 — priority review granted REGULATORY TIMING GAPS: Average FDA-to-EMA gap: 6 months Average FDA-to-PMDA gap: 12 months Average FDA-to-NMPA gap: 18 months TREND: Gaps narrowing with Project Orbis alignment

5Accelerated Approval Tracking

AI agent monitors accelerated approval, breakthrough therapy, and fast track designations to identify drugs on expedited pathways and track confirmatory trial requirements.

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Track Accelerated Pathways
/investors/press/complianceOpenPageRank
ACCELERATED APPROVAL INTELLIGENCE ════════════════════════════════════════════════════════ RECENT BREAKTHROUGH DESIGNATIONS: vertexpharm.com — VX-548 (acute pain): Granted alnylam.com — ALN-APP (Alzheimer's): Granted CONFIRMATORY TRIALS REQUIRED: Products under accelerated approval: 42 currently Confirmatory trials overdue: 6 products FDA withdrawal proceedings: 2 active DESIGNATION PIPELINE: Breakthrough Therapy: 34 new designations (Q1 2026) Fast Track: 28 new designations RMAT (regenerative): 8 new designations

6Post-Marketing Requirements

AI agent monitors post-marketing commitment and requirement fulfillment across pharma domains to track compliance, study completion, and potential label changes.

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Track PMR/PMC Compliance
/compliance/investors/pressOpenPageRank
POST-MARKETING REQUIREMENT TRACKER ════════════════════════════════════════════════════════ ON TRACK: bms.com — Reblozyl PMR: Confirmatory study enrolling lilly.com — Mounjaro PMR: Cardiovascular outcomes study ongoing AT RISK: acceleron-archive.com — Sotatercept PMR /compliance: Study enrollment behind schedule SIGNAL: FDA may issue enforcement letter PMR STATUS INDUSTRY-WIDE: Total active PMRs: 1,200+ On schedule: 72% Delayed: 22% Overdue: 6%

7Regulatory Guidance Tracking

AI agent monitors FDA, EMA, and ICH domains for new guidance documents, draft guidances, and regulatory framework changes that impact drug development strategies.

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Track Regulatory Guidance Updates
/docs/press/complianceCountries
REGULATORY GUIDANCE INTELLIGENCE ════════════════════════════════════════════════════════ NEW GUIDANCE ISSUED: FDA: AI/ML in Drug Development — Final guidance FDA: Decentralized Clinical Trials — Draft guidance EMA: Cell-Based Therapy Products — Revised guideline IMPACT ASSESSMENT: AI/ML guidance: Enables AI-assisted clinical endpoints DCT guidance: Broader remote monitoring accepted Cell therapy: New potency assay requirements UPCOMING GUIDANCE (ANTICIPATED): FDA: Accelerated approval reform — Q2 2026 EMA: Biosimilar interchangeability — Q3 2026

8CMC & Manufacturing Compliance

AI agent monitors CMC-related regulatory signals across pharma and CDMO domains to track facility inspections, supplement filings, and manufacturing compliance.

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Track CMC Regulatory Compliance
/compliance/press/productsCountries
CMC COMPLIANCE INTELLIGENCE ════════════════════════════════════════════════════════ WARNING LETTERS ISSUED: emergent-biosolutions.com /compliance: FDA Warning Letter — Bayview facility /press: Manufacturing operations suspended SIGNAL: Critical CDMO risk — activate backup supplier CLEAN INSPECTIONS: lonza.com — All sites: No observations samsung-biologics.com — Incheon: EIR issued CMC SUPPLEMENT FILINGS: Site transfers: 14 active | Process changes: 22 pending Average approval time: 8-12 months

9Orphan Drug Designation

AI agent monitors orphan drug designation applications, grants, and exclusivity expirations to track rare disease competitive dynamics and regulatory incentive strategies.

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Track Orphan Drug Activity
/products/investors/complianceIAB Categories
ORPHAN DRUG DESIGNATION TRACKER ════════════════════════════════════════════════════════ NEW ORPHAN DESIGNATIONS (Q1 2026): Total granted: 48 designations Gene therapy: 12 | Cell therapy: 8 | Small molecule: 18 | Biologics: 10 ORPHAN EXCLUSIVITY IMPACT: Products with active 7-year ODE: 340+ ODE expirations 2026: 28 products Competing designations in same diseases: Often 3-5 per indication STRATEGY INSIGHT: ODE increasingly challenged — "same disease" interpretation narrowing Multiple orphan drugs approved in same indication becoming common

10Regulatory Strategy Dashboard

AI agent synthesizes all regulatory intelligence into an executive dashboard — providing leadership with real-time visibility into submission pipeline, approval probabilities, and regulatory risks.

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Generate Regulatory Dashboard
/compliance/investors/pressOpenPageRankCountries
REGULATORY DASHBOARD — FEBRUARY 2026 ════════════════════════════════════════════════════════ SUBMISSION PIPELINE: NDA/BLA pending: 3 | sBLA pending: 5 PDUFA dates next 12 months: 6 decisions Approval probability (weighted avg): 78% GLOBAL STATUS: FDA: 3 under review | EMA: 2 under review PMDA: 1 under review | NMPA: 2 filed COMPLIANCE: PMR status: All on track CMC supplements: 2 pending
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Generate Regulatory Report

Regulatory Intelligence Report — February 2026

EXECUTIVE SUMMARY ──────────────────────────────────────── Companies monitored for regulatory activity: 1,800 domains Regulatory submissions tracked: 280 globally Advisory committees monitored: 24 scheduled Guidance documents tracked: 45 new/updated KEY INSIGHTS Three PDUFA dates in next 6 months with 78% weighted approval probability. FDA accelerated approval reform expected — prepare confirmatory strategies. Global regulatory alignment improving through Project Orbis and OPEN. CMC compliance remains critical risk — 2 CDMOs flagged this quarter. Orphan drug exclusivity becoming less protective as competition increases.
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