The intelligence platform for life sciences Regulatory, quality, safety, clinical, commercial and supply chain data from the FDA and regulators worldwide, connected by product, company and facility.

Medical devices

Premarket submissions, registrations and device identifiers.

• FDA 510(k), De Novo, PMA, HDE and Emergency Use Authorizations (EUA)
• FDA product codes and classification, with regulatory assessment
• 510(k) predicate trees
• GUDID (US UDI), EUDAMED (EU) and the GUDID–EUDAMED crosswalk
• FDA device and establishment registration and listing
• PMDA approved devices (Japan)

Drugs, biologics and vaccines

Approvals, labels, products, substances and shortages.

• Drugs@FDA approvals and approval documents, including complete response letters
• Orange Book, DailyMed labels and the NDC directory
• UNII substances and inactive ingredients
• FDA approved vaccines and their documents
• FDA drug establishment registrations
• Drug shortages (FDA and ASHP)
• PMDA approved drugs (Japan)

Safety and postmarket surveillance

Adverse events and recalls, with safety-signal analytics.

• MAUDE medical device adverse event reports
• FAERS drug and biologic adverse event reports
• VAERS vaccine adverse event reports
• FDA recalls for devices and all other product types, and FDA recall alerts
• Adverse events, recalls and field safety notices from regulators outside the US
• Safety signals by device brand and manufacturer, drug and manufacturer, and vaccine and lot

FDA compliance and inspections

The inspection and enforcement history behind FDA-regulated sites.

• FDA inspections and their classifications
• Inspection citations by CFR section
• 483, EIR and CRL documents
• Warning letters
• FEI establishment profiles and Compliance Assessment Reports
• FDA investigator profiles
• Compliance Program Guidance Manuals (CPGM)

Global regulators

Inspections, certificates, licenses and registrations beyond the FDA.

• EU
• UK
• Canada
• Switzerland
• Japan
• WHO

• Health Canada inspections, citations, establishments and licences
• MHRA (UK) GMP and GDP, paediatric investigation plans and e-cigarettes
• EMA EudraGMDP certificates and inspections, sites and API registrations
• Swissmedic GMP and GDP
• WHO prequalification inspections
• PMDA (Japan) inspections and establishments
• UK NHS Freedom of Information data

Clinical trials and literature

Study designs, sites and outcomes, plus the peer-reviewed evidence.

• ClinicalTrials.gov studies, with facilities, contacts and outcome measures
• WHO International Clinical Trials Registry Platform (ICTRP)
• Peer-reviewed literature

Commercial and market access

How US payers cover devices, drugs and procedures, and what is paid for them.

• Aetna
• Anthem
• Cigna
• Empire Blue
• UnitedHealthcare

• Clinical and medical coverage policies
• Linked to the devices, trials and literature they reference
• Industry and research payments, and procedure and drug prices (Commercial module)

Regulations, guidance and standards

The rules, guidance and consensus standards behind every submission.

• FDA guidance documents
• FDA recognized consensus standards
• MDCG, IMDRF/GHTF and ICH guidance
• Regulations and guidance from regulators worldwide
• FDA dockets on Regulations.gov
• The Orca1 document library

Companies and facilities

One profile per company, with its activity across the datasets.

• The Orca1 company index (OMI)
• FDA device and drug establishments
• Company and facility pages that bring every linked record together