FDA Source Material
FDA guidance documents, product labels, enforcement materials, device classification, recall, and adverse-event records drawn from FDA and AccessData FDA.
Data Sources
Arca draws on authoritative regulatory, clinical, medical, public-health, and standards sources from the United States and around the world.
Data Sources
U.S. Regulatory, Drug & Device Sources
Core U.S. drug and device records drawn from the FDA and related federal regulatory systems.
openFDA
Public FDA API records for drug labels, FAERS adverse events, drug recalls, device 510(k), classification, MAUDE events, device recalls, and PMA records.
Drugs@FDA
FDA drug application, approval, product, and regulatory-action records.
FDA Complete Response Letters
Public FDA Complete Response Letters describing deficiencies that prevented an application from being approved in its submitted form.
FDA 510(k) Summary PDFs
FDA-hosted 510(k) decision summaries and supporting clearance documentation.
DailyMed
Structured product labeling and SPL records from the National Library of Medicine.
AccessGUDID
Unique Device Identification records from the Global Unique Device Identification Database.
Federal Regulatory Materials
Medical and healthcare regulatory materials from eCFR, Federal Register, Regulations.gov, GovInfo, and the U.S. Code.
Data Sources
Clinical Trials & Biomedical Literature
Trial registries and biomedical publication records from the major research databases.
ClinicalTrials.gov
Clinical trial registrations, study status, interventions, outcomes, sponsors, and trial metadata via ClinicalTrials.gov v2.
PubMed / NCBI
Biomedical literature records from PubMed and NCBI E-utilities.
PubMed Central
An authoritative archive of open-access biomedical and life-sciences journal literature that Arca can draw from.
Europe PMC
Biomedical publication records and abstracts, with links to full text where available, from Europe PMC.
Global Index Medicus
WHO-supported global health literature and regional medical indexes.
Data Sources
Public Health, Guidelines & Evidence
Public-health guidance, surveillance data, and evidence-based clinical recommendations.
CDC
CDC guidance, public-health publications, surveillance materials, and health topic resources.
CDC Data Catalog
Public datasets and metadata from the CDC open data catalog.
CDC WONDER
CDC public-health datasets and epidemiological data resources.
World Health Organization
Global public-health guidance, disease information, reports, and policy resources from WHO.
AHRQ
Healthcare evidence, quality, outcomes, and effective-healthcare resources from the Agency for Healthcare Research and Quality.
USPSTF
Clinical preventive-service recommendations from the U.S. Preventive Services Task Force.
NICE
Clinical guidance, health-technology assessments, and evidence resources from the National Institute for Health and Care Excellence.
Cochrane Library
Systematic reviews and clinical evidence summaries from Cochrane.
Data Sources
Standards, Quality & Harmonization
Pharmacopeial standards and international harmonization guidance for quality and regulatory practice.
ICH
International Council for Harmonisation quality, safety, efficacy, and multidisciplinary guidelines.
PIC/S
Pharmaceutical Inspection Co-operation Scheme GMP guidance and inspection resources.
USP / USP-NF
United States Pharmacopeia standards and USP-NF reference material.
IMDRF
International Medical Device Regulators Forum guidance for medical-device regulatory harmonization.
Data Sources
European & Global Regulatory Sources
Medicines and medical-device regulatory materials from Europe and major global health authorities.
EMA
European Medicines Agency guidance, assessments, medicine information, and regulatory resources.
European Commission Health
Broader EU health-policy, medical-device, and pharmaceutical regulatory materials from the European Commission, alongside the MDR and IVDR expert-panel opinions listed separately.
EU MDR CECP Expert Panel Opinions
European Commission expert-panel opinions issued through the MDR clinical evaluation consultation procedure.
EU IVDR PECP Expert Panel Views
European Commission expert-panel views and consultations under the IVDR performance evaluation consultation procedure.
EUR-Lex
EU regulations and directives, including MDR, IVDR, and related health and product legislation.
UK Government Health Sources
UK government health, medicine, device, and regulatory policy material.
MHRA
UK medicines and medical-device safety, licensing, guidance, and enforcement resources.
Health Canada
Canadian drug, biologic, medical-device, product-safety, and health-regulatory materials.
PMDA
Japanese pharmaceuticals and medical-device review, safety, and regulatory information.
TGA
Australian therapeutic goods regulation, safety updates, guidance, and product information.
