Drug & Device Intelligence

Regulatory Intelligence — Directly Linked to Your Trials

Connect every clinical trial in your portfolio to FDA drug approvals, EMA medicines, medical device classifications, patent landscapes, and safety data — automatically enriched from 18+ authoritative databases.

29,600+

FDA Drug Products

177,000+

FDA Device Submissions

5,100,000+

GUDID Identifiers

397,000+

Verified Drug-Trial Links

The Problem

Regulatory intelligence and clinical trial data live in separate worlds. Teams manually cross-reference FDA approvals, EMA authorizations, patent expiration dates, and device classifications against their trial portfolios. This takes hours, introduces errors, and means critical competitive signals are discovered too late.

The Solution

ClinicaLister automatically links your followed clinical trials to relevant drugs and devices across FDA and EMA databases. AI-powered matching identifies connections, community validation ensures accuracy, and deep enrichment provides patent, exclusivity, safety, and substance data.

Four Data Views

The Drug & Device Intelligence module provides four integrated views:

Verified Drug Links

Confirmed drug-trial associations with full FDA/EMA regulatory data

AI-Suggested Drug Links

AI-identified potential matches with confidence scores and community validation

Verified Device Links

Confirmed device-trial associations with classification, safety, and GUDID data

AI-Suggested Device Links

AI-identified device matches pending community validation

FDA Drug Integration

Access comprehensive regulatory data on 29,600+ FDA-approved drug products, enriched with Orange Book, patent, and exclusivity intelligence.

Regulatory Data

  • Brand name, generic name, and active ingredients
  • Marketing status and approval type
  • Application and product numbers
  • Reference listed drug status
  • Approval date and sponsor information

Formulation & Administration

  • Dosage form (automatically split for compound entries)
  • Strength and route of administration
  • NDC product listings with marketing dates and DEA schedule

Patent & Exclusivity Intelligence

  • Patent expiration dates with active/expired status indicators
  • Marketing exclusivity periods with color-coded alerts
  • Exclusivity type codes (NCE, Orphan, Pediatric, and more)
  • First generic available date with availability status

Safety & Designations

  • Adverse events summary with top reported reactions from FAERS
  • REMS (Risk Evaluation and Mitigation Strategy) requirements
  • Orphan drug, fast track, and breakthrough therapy designations
  • Biosimilar products with Purple Book data and interchangeability status

EMA Drug Integration

European Medicines Agency data from EPAR covering 2,700+ centrally authorized medicines across EU member states.

  • Medicine name and active substance
  • Therapeutic area classification
  • Authorization status with color-coded indicators
  • Conditional approval and exceptional circumstances designations
  • Marketing authorization holder and MAH country
  • Biosimilar and generic medicine status flags
  • ATC (Anatomical Therapeutic Chemical) classification codes

FDA Device Integration

Comprehensive medical device regulatory data covering 177,000+ FDA device submissions across all major submission pathways.

Submission Data

  • • Submission type: 510(k), PMA, HDE, DE NOVO
  • • Submission number and decision date
  • • Applicant name and location
  • • Predicate device information

Classification & Safety

  • • FDA device class (I, II, III)
  • • Medical specialty and advisory committee
  • • Implant and life-sustaining flags
  • • Expedited review indicators

GUDID Cross-Reference

  • • 5M+ device identifiers
  • • MRI safety status
  • • Latex content and sterilization
  • • Single-use and Rx/OTC flags

AI-Powered Matching with Crowd Validation

ClinicaLister's AI engine identifies potential drug-trial and device-trial relationships using advanced matching algorithms. Every suggestion is transparent, scored, and community-validated.

1

Entity Extraction

Reads trial titles, summaries, eligibility, and intervention text

2

Multi-Signal Matching

Candidate drugs and devices matched across multiple independent signals

3

Confidence Scoring

Every link graded High, Medium, or Low confidence

4

Independent Quality Assurance

Each link is automatically quality-checked before it's surfaced

5

Community Validation

Verified links can be confirmed by the community

By the Numbers

397,000+
Verified Drug-Trial Links
44,800+
Verified Device-Trial Links
FDA + EMA
Independently quality-checked, with full provenance on every link

Deep Enrichment Pipeline

Every drug and device link is enriched by cross-referencing multiple authoritative databases:

GSRS

UNII codes, molecular formulas, molecular weight, CAS numbers, substance class

MAUDE

FDA adverse event reports — event narratives, patient demographics, severity outcomes

FDA Device Recalls

Recall classification, status, recalling firm, reason, distribution pattern

FDA Device Classifications

Product code classifications, medical specialty, device class, review panel

GUDID

Device identifiers, brand names, MRI safety, latex content, sterilization methods

Orange Book

Therapeutic equivalence, patent listings, exclusivity data for FDA-approved drugs

NDC Directory

National Drug Code product listings with marketing dates, DEA schedule

EU Clinical Trials (CTIS)

Cross-references to EU trials — trial numbers, status, phase, recruiting states

DailyMed

FDA-approved drug labeling, package inserts, medication guides, and prescribing information

NADAC

National Average Drug Acquisition Cost — retail pharmacy pricing data for cost intelligence

Drug Shortages

Active FDA drug shortage tracking with supply status and estimated resolution dates

PubMed / Europe PMC

Trial-linked publications providing evidence context and research citations

CMS Open Payments

Physician and teaching hospital payment data from pharmaceutical and device manufacturers

See how regulatory intelligence integrates directly into your trial workflow