FDA.gov
FDA guidance, safety communications, enforcement materials, recalls, approvals, and the AI-enabled medical-device list.
Data Sources
Research across primary medical evidence, multidisciplinary scientific literature, and authoritative regulatory records from the United States and around the world.
Coverage
The sources behind every answer
Jump to a domain to review the publication indexes, primary records, registries, guidelines, and regulatory collections in that part of the research corpus.
FDA Records
Primary U.S. drug, biologic, device, labeling, approval, and regulatory-action records from FDA systems.
9 sources
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.
U.S. Regulatory Guidance
Authoritative U.S. guidance, regulations, rulemaking records, statutes, and official government publications.
6 sources
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.
Biomedical Literature
Biomedical publications and regional literature indexes spanning North America, Europe, Latin America, and global health.
8 sources
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.
Clinical Trials
Trial registrations, status, interventions, outcomes, sponsors, and regional registry records from the United States and Latin America.
5 sources
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.
Scientific Literature & Citation Graph
Multidisciplinary paper discovery through the Semantic Scholar Academic Graph and its documented scholarly-data ecosystem.
12 sources
Semantic Scholar documents more than 50 publisher, data-provider, preprint, and crawler inputs. The named source families below reflect its public corpus documentation; additional partner and web-indexed coverage is represented as a combined family.
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.
Publisher, Society & Web-Indexed Literature
Additional publisher feeds, scholarly societies, university presses, repositories, and academic pages discovered through Semantic Scholar's partner network and web crawler.
Public Health
Public-health guidance, surveillance datasets, epidemiological records, and regional and global health resources.
6 sources
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.
Global Index Medicus
WHO-supported health literature from regional indexes around the world.
Clinical Guidelines
Evidence reviews, clinical recommendations, preventive-service guidance, and health-technology assessments.
5 sources
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.
Standards & Quality
Pharmacopeial standards and international harmonization, inspection, quality, and medical-device guidance.
7 sources
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.
Global Regulatory
Primary medicines, biologics, medical-device, and health-regulatory authorities across global and regional jurisdictions.
71 sources
Global
World Health Organization
Global health guidance, norms, standards, prequalification, safety, and regulatory-system resources.
IMDRF
International medical-device regulatory harmonization and shared policy resources.
Americas & Caribbean
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.
Europe & Eurasia
European Union — EMA
EU medicines guidance, European Public Assessment Reports (EPARs), EudraVigilance safety information, product records, and authorization materials.
European Commission — Health & Legislation
EU health policy and legislation, CTIS trial records, and MDR CECP and IVDR PECP expert-panel opinions.
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.
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.
Asia-Pacific
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.
Middle East & North Africa
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.
Sub-Saharan Africa
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.
