Data sources

FDA.gov

FDA guidance, safety communications, enforcement materials, recalls, approvals, and the AI-enabled medical-device list.

AccessData FDA

FDA application and product databases, including Drugs@FDA, 510(k) summaries, PMA, MAUDE, and related records.

openFDA / API FDA

Public APIs for drug labels, FAERS and MAUDE events, recalls, device submissions, classifications, and enforcement records.

FDA Labels

FDA-hosted prescribing information and product-label search for approved drugs and biological products.

Orange Book

Approved drug products with therapeutic-equivalence evaluations, patents, and exclusivity information.

Purple Book

FDA records for licensed biological products, biosimilars, and interchangeable biosimilar products.

NCTR Complete Response Letter Search

FDA Complete Response Letters describing deficiencies that prevented approval in the submitted form.

DailyMed

Structured product labeling and current SPL records from the National Library of Medicine.

AccessGUDID

Unique Device Identification records from the Global Unique Device Identification Database.

FDA Warning Letters

Full text of FDA warning letters to manufacturers, sponsors, and facilities, indexed by firm, subject, and issuing office.

FDA Form 483 Inspectional Observations

Form 483 observations released through FDA's FOIA electronic reading room, linked to the inspected establishment.

FDA Inspection Classifications

Inspection outcomes (NAI, VAI, OAI) by establishment, project area, and date from the FDA Data Dashboard.

FDA Import Refusals

Shipments refused at the U.S. border with the refusing division, product, firm, and charge codes.

FDA Enforcement Reports (iRES)

Weekly enforcement-report recalls for drugs, devices, biologics, and food, with recall class, reason, and distribution.

FDA Premarket Submission Documents

510(k) summaries, PMA summaries of safety and effectiveness (SSEDs), Drugs@FDA review packages, and the AI-enabled device list.

FDA Device Databases

De Novo, HDE, TPLC, product classification, establishment registration & listing, and recognized consensus standards.

FDA Advisory Committee Materials

Briefing documents, meeting transcripts, and voting outcomes from FDA advisory committee meetings.

FDA Drug Reference Databases

Drug shortages, the NDC Directory, the Inactive Ingredient Database, and postmarketing requirements and commitments.

FDA MAUDE

Manufacturer and User Facility Device Experience reports: medical-device adverse events and malfunctions reported to FDA.

FDA Device Recalls

Medical-device recalls and enforcement actions with recall class, product, and root cause.

Health Canada — Medical Device Incidents & Recalls

Canadian medical-device incident reports and recall listings.

MHRA — Field Safety Notices & Alerts

UK field safety notices, device safety information, and medical-device alerts.

Swissmedic — Field Safety Notices

Swiss medical-device field safety corrective actions and recalls.

BfArM — Device Risk Information

German customer information and field corrective actions for medical devices.

ANSM — Device Vigilance

French materiovigilance and reactovigilance notices and safety information.

AEMPS — Product Alerts

Spanish medical-device safety alerts and field safety notices.

IGJ — Field Safety Notices

Dutch Health and Youth Care Inspectorate medical-device safety notices.

HPRA — Safety Notices

Irish medical-device safety notices and field safety corrective actions.

DKMA — Device Safety Alerts

Danish Medicines Agency medical-device recalls and safety alerts.

MFDS — Device Safety Information

South Korean medical-device recalls and safety notices.

PMDA — Medical Device Safety

Japanese medical-device recall notices and safety information.

ANVISA — Tecnovigilância

Brazilian medical-device field actions and adverse-event alerts.

TGA — DAEN & Recall Actions

Australia's Database of Adverse Event Notifications and System for Australian Recall Actions.

EUDAMED

The European database on medical devices: actor registration, UDI/device records, certificates, and vigilance modules.

NANDO

Notified body designations and scopes under the MDR and IVDR.

MDCG Guidance

Medical Device Coordination Group guidance on clinical evaluation, PMCF, classification, UDI, and notified-body procedures.

Harmonised Standards under MDR / IVDR

Official Journal listings of harmonised standards and common specifications that give presumption of conformity.

EMDN Nomenclature

The European Medical Device Nomenclature used for EUDAMED registration and certificate scopes.

Team-NB

Notified-body association position papers, best-practice guides, and code of conduct.

BSI — Notified Body Resources

BSI notified-body guidance, technical-documentation expectations, and MDR/IVDR whitepapers.

TÜV SÜD — Notified Body Resources

TÜV SÜD conformity-assessment guidance, certification timelines, and regulatory updates.

FAERS Public Dashboard

The FDA Adverse Event Reporting System for drugs and therapeutic biologics, by product, reaction, and outcome.

VAERS

The U.S. Vaccine Adverse Event Reporting System run by CDC and FDA.

EudraVigilance — ADR Reports

European suspected adverse-drug-reaction reports for centrally and nationally authorised medicines.

WHO VigiAccess

Public view of VigiBase, the WHO global database of individual case safety reports.

MHRA Yellow Card

UK adverse-reaction reports for medicines, vaccines, and medical devices, with interactive drug analysis profiles.

Canada Vigilance

Health Canada's adverse-reaction database for drugs, biologics, and natural health products.

Lareb

The Netherlands Pharmacovigilance Centre's reports and safety signals.

TGA — DAEN Medicines

Australia's adverse-event notifications for medicines and vaccines.

FDA Guidance & Regulatory Materials

Agency guidance documents, compliance policies, rulemaking notices, and regulatory information.

Electronic Code of Federal Regulations

The continuously updated online edition of federal agency regulations, including Title 21.

Federal Register

Proposed and final rules, notices, and presidential documents published by the U.S. government.

Regulations.gov

Federal rulemaking dockets, supporting materials, notices, and public comments.

GovInfo

Authenticated publications from all three branches of the U.S. federal government.

United States Code

The official subject-matter codification of the general and permanent laws of the United States.

PubMed

Biomedical and life-sciences citations, abstracts, publication types, and controlled vocabulary records.

NCBI

National Center for Biotechnology Information databases, tools, and integrated life-sciences records.

PubMed Central

A full-text archive of biomedical and life-sciences journal literature.

Europe PMC

Biomedical publication records, abstracts, citations, grants, and available full text.

WHO Global Index Medicus

WHO-supported global health literature and regional medical indexes.

LILACS

Latin American and Caribbean health-sciences literature indexed through BIREME/PAHO/WHO.

BVS / Virtual Health Library

Regional health-sciences databases and evidence resources from the Virtual Health Library network.

SciELO

Open-access scholarly journals and collections, including the global and Brazil portals.

OpenAlex

Open index of scholarly works, authors, institutions, and citations across every discipline.

Google Scholar

Broad scholarly web index for grey literature, theses, and citation discovery.

Embase

Elsevier's biomedical and pharmacological database with Emtree indexing, via your institutional subscription.

Scopus

Elsevier's abstract and citation database, via your institutional subscription.

ClinicalTrials.gov

U.S. and international clinical-study registrations and results through the ClinicalTrials.gov registry.

FDA Clinical Trial Information

FDA requirements, guidance, safety communications, and public information related to clinical investigations.

ReBEC — Brazil

Brazilian Registry of Clinical Trials and a WHO-recognized primary registry.

RPCEC — Cuba

Cuban Public Registry of Clinical Trials and a WHO-recognized primary registry.

REPEC — Peru

Peru's national registry of authorized clinical trials and related study information.

EU CTIS

The Clinical Trials Information System: EU trial applications, decisions, and results under the Clinical Trials Regulation.

EU Clinical Trials Register

Legacy EudraCT protocol and results records for trials started before CTIS.

WHO ICTRP

The International Clinical Trials Registry Platform aggregating primary registries worldwide.

ISRCTN

UK-based primary registry for clinical studies across all therapeutic areas.

DRKS — Germany

The German Clinical Trials Register.

jRCT — Japan

The Japan Registry of Clinical Trials.

ANZCTR

The Australian New Zealand Clinical Trials Registry.

ChiCTR — China

The Chinese Clinical Trial Registry.

CTRI — India

The Clinical Trials Registry – India.

Semantic Scholar Academic Graph

A multidisciplinary graph of 200M+ papers linking authors, venues, citations, abstracts, external identifiers, and available full text.

Crossref

DOI-centered scholarly metadata supplied by publishers and registration agencies across journals, proceedings, books, and preprints.

arXiv

Open preprints spanning physics, mathematics, computer science, quantitative biology, statistics, economics, and related fields.

bioRxiv & medRxiv

Preprints across biology, medicine, clinical research, epidemiology, and health sciences before peer review.

Springer Nature

Journal, book, conference, and reference literature across the natural sciences, medicine, engineering, and social sciences.

Wiley Online Library

Peer-reviewed journals, reference works, and research across medicine, life sciences, chemistry, engineering, and other disciplines.

Taylor & Francis Online

Scholarly journals spanning science, technology, medicine, social science, and the humanities.

SAGE Journals

Peer-reviewed research across health sciences, social science, methods, education, engineering, and related fields.

ACM Digital Library

Computing and information-technology journals, conference proceedings, magazines, and technical publications.

IEEE Xplore

Engineering, computer science, biomedical technology, standards, journals, and conference literature from IEEE and partners.

Unpaywall

Open-access location metadata that connects scholarly records to legally available article copies.

Additional publisher feeds, scholarly societies, university presses, repositories, and academic pages discovered through Semantic Scholar's partner network and web crawler.

CDC

U.S. public-health guidance, disease information, surveillance materials, and health-topic resources.

CDC Open Data

Public datasets and metadata from the CDC open-data catalog.

CDC WONDER

Public-health datasets and query tools for mortality, births, disease, and population data.

World Health Organization

Global public-health guidance, disease information, reports, standards, and policy resources.

Pan American Health Organization

Regional public-health guidance, data, and programs across the Americas.

ECDC

European Centre for Disease Prevention and Control surveillance data, risk assessments, and public-health guidance.

Global Index Medicus

WHO-supported health literature from regional indexes around the world.

AHRQ

Healthcare evidence, quality, outcomes, and research resources from the Agency for Healthcare Research and Quality.

AHRQ Effective Health Care

Comparative-effectiveness reviews, evidence reports, methods guidance, and stakeholder resources.

USPSTF

Evidence-based clinical preventive-service recommendations from the U.S. Preventive Services Task Force.

NICE

Clinical guidance, quality standards, health-technology assessments, and evidence resources.

Cochrane Library

Systematic reviews, protocols, and controlled-trial evidence from Cochrane's evidence collections.

ICH

International Council for Harmonisation quality, safety, efficacy, and multidisciplinary guidelines.

PIC/S

Pharmaceutical Inspection Co-operation Scheme GMP guidance and inspection resources.

USP

United States Pharmacopeia standards, quality resources, and scientific guidance.

USP–NF

Compendial monographs, general chapters, and official United States Pharmacopeia–National Formulary standards.

FDA AccessData

FDA-hosted regulatory databases and quality-related product records.

ICH Guideline Database

ICH guideline documents, implementation status, work products, and supporting materials.

IMDRF

International Medical Device Regulators Forum guidance for medical-device regulatory harmonization.

ISO

ISO 13485, 14971, 10993, 14155, and the wider catalogue of quality, risk, and biocompatibility standards.

IEC

IEC 60601, 62304, 62366, and other electrical-safety, software-lifecycle, and usability standards.

AAMI

AAMI standards and technical information reports for device sterilization, software, and quality systems.

ASTM International

ASTM test methods and specifications for materials, packaging, and device performance.

CEN-CENELEC

European standardization bodies publishing EN versions of harmonised standards.

ANSI

The American National Standards Institute catalogue and standards-incorporated-by-reference portal.

EDQM — European Pharmacopoeia

European Pharmacopoeia monographs, Certificates of Suitability, and reference standards.

GMDN Agency

The Global Medical Device Nomenclature used for UDI and regulatory submissions.

ISPE

ISPE GAMP and Baseline Guides for pharmaceutical engineering, validation, and data integrity.

PDA

Parenteral Drug Association technical reports on sterile manufacturing, aseptic processing, and quality.

CMS Coverage Database

Medicare National and Local Coverage Determinations, billing codes, and coverage with evidence development.

EU HTA Regulation & Joint Clinical Assessments

European joint clinical assessments and joint scientific consultations under Regulation (EU) 2021/2282.

Germany — G-BA

Federal Joint Committee benefit assessments, method evaluations, and reimbursement decisions.

Germany — IQWiG

Institute for Quality and Efficiency in Health Care dossier assessments and evidence reports.

France — HAS

Haute Autorité de Santé opinions on medicines and devices, including CNEDiMTS device assessments.

Netherlands — Zorginstituut

Dutch National Health Care Institute package advice and reimbursement assessments.

Canada's Drug Agency

Formerly CADTH: reimbursement reviews and health-technology assessments.

Scotland — SMC

Scottish Medicines Consortium advice on the clinical and cost-effectiveness of new medicines for NHSScotland.

ICER

Institute for Clinical and Economic Review cost-effectiveness and value assessments.

Australia — PBAC

Pharmaceutical Benefits Advisory Committee outcomes and public summary documents.

USPTO

Patent Public Search, PTAB decisions, and the Patent Center file wrapper.

Google Patents

Full-text search across patents and applications from more than 100 offices.

EPO Espacenet

European Patent Office worldwide patent search and European Patent Register.

WIPO PATENTSCOPE

International PCT applications and national collections from the World Intellectual Property Organization.

SEC EDGAR

10-K, 10-Q, 8-K, and S-1 filings for competitor pipelines, risk factors, and regulatory disclosures.

World Health Organization

Global health guidance, norms, standards, prequalification, safety, and regulatory-system resources.

IMDRF

International medical-device regulatory harmonization and shared policy resources.

Canada — Health Canada

Federal drug, biologic, medical-device, product-safety, and health-regulatory materials.

PAHO / PANDRH

Pan-American health and regulatory-harmonization resources for the Americas.

MERCOSUR

Regional policy, resolutions, and technical regulations for MERCOSUR member states.

SIECA

Central American economic-integration rules and regional technical-regulation resources.

Argentina — ANMAT

Argentina's national authority for medicines, food, and medical technology.

Brazil — ANVISA

Brazil's health-regulatory agency for medicines, biologics, devices, and health products.

Chile — ISP

Chile's public-health institute and national medicines and medical-device authority.

Colombia — INVIMA

Colombia's national institute for medicines, food, devices, and sanitary surveillance.

Cuba — CECMED

Cuba's national authority for medicines, equipment, and medical devices.

Mexico — COFEPRIS

Mexico's federal commission for protection against health risks.

Peru — DIGEMID

Peru's directorate for medicines, supplies, and drugs.

Ecuador — ARCSA

Ecuador's national agency for regulation, control, and sanitary surveillance.

Bolivia — AGEMED

Bolivia's state agency for medicines and health technologies.

Paraguay — DINAVISA

Paraguay's national directorate for sanitary surveillance.

Caribbean — CARPHA

Regional public-health and regulatory-system resources for Caribbean member states.

European Union — EMA

EU medicines guidance, European Public Assessment Reports (EPARs), EudraVigilance safety information, product records, and authorization materials.

HMA & CMDh

Heads of Medicines Agencies network guidance, and CMDh procedures for mutual-recognition and decentralised authorizations.

European Commission — Health & Legislation

EU health policy and legislation, CTIS trial records, and MDR CECP and IVDR PECP expert-panel opinions.

EU MDR / IVDR Expert Panels

Clinical Evaluation Consultation Procedure (CECP) opinions under the MDR and Performance Evaluation Consultation Procedure (PECP) views under the IVDR.

United Kingdom — Government & MHRA

UK medicines and medical-device policy, licensing, safety, guidance, and enforcement.

Switzerland — Swissmedic & Swissdamed

Swiss therapeutic-product regulation and the national medical-device database.

France — ANSM

France's national agency for the safety of medicines and health products.

Germany — BfArM & PEI

German federal regulation of medicines, devices, vaccines, and biomedicines.

Ireland — HPRA

Ireland's health-products regulatory authority for medicines, devices, and controlled products.

Italy — AIFA

Italy's medicines agency for authorization, reimbursement, safety, and regulatory policy.

Netherlands — CBG-MEB

The Dutch medicines evaluation board and national medicine-information resources.

Sweden — MPA

Sweden's Medical Products Agency for medicines and medical devices.

Spain — AEMPS

Spain's agency for medicines and health products.

Portugal — INFARMED

Portugal's national authority for medicines and health products.

Austria — BASG

Austria's federal office for healthcare safety and medicines oversight.

Denmark — DMA

The Danish Medicines Agency's authorization, safety, reimbursement, and device resources.

Belgium — FAMHP

Belgium's federal agency for medicines and health products, in English, French, and Dutch.

Poland — URPL

Poland's office for the registration of medicinal products, medical devices, and biocidal products.

Czechia — SÚKL

The Czech State Institute for Drug Control's authorizations, safety information, and device oversight.

Slovakia — ŠÚKL

Slovakia's State Institute for Drug Control for medicines and medical devices.

Hungary — OGYÉI

Hungary's national authority for medicines, medical devices, and pharmacy.

Romania — ANMDMR

Romania's national agency for medicines and medical devices.

The Bulgarian Drug Agency's authorizations, pharmacovigilance, and medicines registers.

Greece — EOF

The Greek National Organization for Medicines' authorizations, safety notices, and device oversight.

Croatia — HALMED

Croatia's agency for medicinal products and medical devices.

Slovenia — JAZMP

Slovenia's agency for medicinal products and medical devices.

Finland — Fimea

The Finnish Medicines Agency's authorizations, safety information, and medicines guidance.

Norway — DMP

The Norwegian Medical Products Agency, formerly the Norwegian Medicines Agency, for medicines and medical devices.

Iceland — Icelandic Medicines Agency

Iceland's authority for medicines, medical devices, and pharmacovigilance.

The Estonian State Agency of Medicines' authorizations, safety information, and device oversight.

Latvia — ZVA

Latvia's State Agency of Medicines for medicines, medical devices, and pharmacovigilance.

Lithuania — VVKT

Lithuania's State Medicines Control Agency for authorizations, safety, and medicines registers.

Malta — Medicines Authority

Malta's medicines regulator for authorizations, pharmacovigilance, and inspections.

Ukraine — DEC

Ukraine's State Expert Center regulatory, registration, and pharmacovigilance resources.

Uzbekistan — Pharmaceutical Products Safety Center

Uzbekistan's medicines and medical-products safety and regulatory information.

Eurasian Economic Commission

Eurasian Economic Union medicines, medical-device, and technical-regulation materials.

Japan — PMDA

Japanese pharmaceuticals and medical-device review, safety, and regulatory information.

Australia — TGA

Australian therapeutic-goods regulation, safety updates, guidance, and product information.

China — NMPA & CDE

China's medicines and medical-device regulator and Center for Drug Evaluation resources.

South Korea — MFDS

Korean medicines, biologics, medical-device, safety, and product-information resources.

Taiwan — TFDA

Taiwan Food and Drug Administration regulatory and product-safety information.

Hong Kong — Drug Office

Hong Kong medicine registration, licensing, safety, and pharmaceutical-service resources.

India — CDSCO & MoHFW

Indian national drug, biologic, device, clinical-trial, and health-policy resources.

Pakistan — DRAP

Pakistan's drug regulatory authority for therapeutic goods and medical devices.

Bangladesh — DGDA

Bangladesh's directorate for medicine licensing, regulation, and safety.

Sri Lanka — NMRA

Sri Lanka's national medicines regulatory authority.

Singapore — HSA

Singapore's regulation of health products, therapeutic products, and medical devices.

Malaysia — NPRA & MDA

Malaysia's pharmaceutical and medical-device regulatory authorities.

Thailand — Thai FDA

Thailand's food, drug, biologic, and medical-device regulatory resources.

Indonesia — BPOM

Indonesia's authority for drug and food control.

Philippines — FDA

Philippine food, medicine, device, and health-product regulatory resources.

Vietnam — DAV

Vietnam's Drug Administration regulatory and product-information resources.

ASEAN

Regional health-product harmonization, standards, and regulatory-cooperation materials.

New Zealand — Medsafe

New Zealand's medicines and medical-device safety authority.

Saudi Arabia — SFDA

Saudi food, medicine, biologic, and medical-device regulatory resources.

United Arab Emirates — EDE

The Emirates Drug Establishment's medical-product regulation and safety resources.

Gulf Health Council

Regional health, procurement, registration, and regulatory-cooperation resources for GCC states.

Egypt — EDA

Egypt's national authority for medicines, biologics, supplies, and medical devices.

Türkiye — TİTCK

Türkiye's medicines and medical-devices agency.

Israel — Ministry of Health

Israeli medicines, medical-device, clinical-trial, and public-health regulatory resources.

Jordan — JFDA

Jordan's food and drug administration and medical-product regulatory resources.

African Medicines Agency

Continental medicines-regulatory coordination and harmonization resources.

South Africa — SAHPRA

South Africa's authority for health products, medicines, radiation control, and medical devices.

Nigeria — NAFDAC

Nigeria's regulator for food, medicines, medical devices, and other controlled products.

Ghana — FDA

Ghana's food, medicine, medical-device, and health-product regulator.

Ethiopia — EFDA

Ethiopia's authority for medicines, medical devices, food, and health products.

East African Community

Regional medicines-regulatory harmonization and technical-policy resources.

Kenya — Pharmacy and Poisons Board

Kenya's medicines, pharmacy, clinical-trial, and medical-device regulator.

Uganda — NDA

Uganda's national drug authority for medicines and health products.

Tanzania — TMDA

Tanzania's medicines and medical-devices authority.

Rwanda — FDA

Rwanda's food and drugs authority for regulated health products.

Zimbabwe — MCAZ

Zimbabwe's medicines-control authority and product-safety resources.

AVAREF

The African Vaccine Regulatory Forum's clinical-trial and regulatory-capacity resources.