Research Datasets: Biomedical, Regulatory, and Market Evidence

Adverse-event reports, recall notices, and post-market public discussion.

• FDA Adverse Event Reporting System (FAERS)

  11M

  Individual adverse-event cases submitted to the FDA, indexed by receipt date.

  Available
• FAERS drug records

  580K

  Drug mentions and reported roles linked to FAERS cases.

  Available
• FDA device adverse event reports (MAUDE)

  25M

  Medical-device adverse-event reports, including death, injury, and malfunction events.

  Available
• FDA recall notices

  58K

  Recall events with reason, classification, initiation date, and distribution.

  Available
• Public patient and clinician discussion

  4.3M

  Public patient and clinician discussion for qualitative safety-signal analysis.

  Available

Device clearances, approvals, classifications, and market registrations.

• FDA 510(k) clearance summaries

  170K

  510(k) clearance decisions and predicate-device relationships.

  Available
• FDA De Novo decisions

  2.6K

  De Novo classification decisions for novel device types.

  Available
• FDA premarket approvals

  56K

  Premarket approval decisions and supplemental applications.

  Available
• Global device identification registry (GUDID)

  5M

  US device-identification records, one record per catalogue number.

  Available
• FDA device classification codes

  4.7K

  Product codes with regulatory class and governing regulation.

  Available
• EU device registry (EUDAMED)

  3M

  European Union medical-device registration records.

  Available
• Health Canada device licences

  300K

  Licensed medical devices in the Health Canada registry.

  Available
• Global device authorizations

  290K

  Medical-device authorizations outside the United States and European Union.

  Available
• Southeast Asian device registrations

  1.8M

  Product registrations from Southeast Asian medical-device regulators.

  Available

Registered clinical trials and indexed biomedical literature.

• ClinicalTrials.gov registry

  590K

  Registered studies with recruitment status, phase, sponsor, and study locations.

  Available
• PubMed bibliographic records

  27M

  Bibliographic records with abstracts and Medical Subject Headings.

  Available

Drug labels, product codes, molecular structures, mechanisms, and targets.

• FDA drug labels

  260K

  Structured prescribing information, including indications, warnings, and dosage.

  Available
• National Drug Code directory

  130K

  Drug products identified by National Drug Code.

  Available
• ChEMBL molecule dictionary

  2.8M

  Molecular entities and compound identifiers.

  Available
• ChEMBL drug mechanisms

  7.5K

  Drug–target mechanisms of action.

  Available
• ChEMBL biological targets

  17K

  Biological targets represented in ChEMBL activity data.

  Available

Provider directories, procedure utilization, payments, awards, and procurement records.

• US provider directory (NPPES)

  9.6M

  US individual and organizational healthcare providers registered in NPPES.

  Available
• Healthcare provider directory

  6.6M

  Provider organizations with hospital and health-system affiliations.

  Available
• NHS organisation directory

  210K

  National Health Service organizations and organizational identifiers.

  Available
• CMS payment rates

  32K

  Medicare payment rates by procedure code and effective period.

  Available
• CMS provider procedure utilization

  10M

  Medicare procedure volumes and payments by provider and reporting period.

  Available
• CMS Open Payments records

  60M

  Industry transfers of value to US clinicians and teaching hospitals.

  Available
• Federal contract awards

  140K

  US federal contract awards with agencies, recipients, values, and action dates.

  Available
• Public procurement notices

  22M

  Public tender notices and contract awards.

  Available
• Legal entity identifiers (GLEIF)

  10M

  Legal Entity Identifiers, registration data, and corporate parent relationships.

  Available
• Southeast Asian registered establishments

  130K

  Registered healthcare establishments and importers in Southeast Asia.

  Available

Statutes, regulations, regulatory guidance, and accredited training programs.

• Codified FDA regulations

  8.3K

  FDA regulations organized by title, part, and section.

  Available
• FDA guidance documents

  2.7K

  Guidance documents with issue dates and publication status.

  Available
• EU Medical Device Regulation

  230

  Regulation (EU) 2017/745 organized by article.

  Available
• EU In Vitro Diagnostic Regulation

  220

  Regulation (EU) 2017/746 organized by article.

  Available
• Federal Food, Drug, and Cosmetic Act

  270

  Federal Food, Drug, and Cosmetic Act organized by section.

  Available
• Accredited clinical training programmes

  14K

  Accredited clinical training programs and sponsoring institutions.

  Available

Patent records, population health indicators, disease-burden estimates, and controlled vocabularies.

• US patent grants

  9M

  US patent grants and pre-grant applications with full text.

  Available
• WHO health indicators

  23K

  Population health measures by indicator, country, and year.

  Available
• Global Burden of Disease estimates

  Not loaded

  Disease-burden estimates by cause, location, age, sex, and year.

  Not loaded
• World Bank development indicators

  70K

  Development measures by indicator, country, and year.

  Available
• Medical Subject Headings (MeSH)

  350K

  Controlled descriptors and hierarchy used to index PubMed records.

  Available
• ICD-10 classification codes

  74K

  Diagnosis and procedure classification codes.

  Available
• RxNorm drug concepts

  2.4M

  Normalized drug concepts, names, and relationships.

  Available