Resources:
FDA Links
- Approvals/Labels (primarily drugs; see device database below for devices)
- CFRs: Code of Federal Register - Title 21
- Compliance Policy Guides
- Device Database
- Enforcement/Recalls/Alerts (primarily biologics)
- Enforcement/Recalls/Alerts (primarily devices)
- Enforcement/Recalls/Alerts (primarily drugs)
- Medical Product Safety Information (MedWatch)
- Guidances (CBER/primarily biologics)
- Guidances (CDER/primarily drugs)
- Guidances (CDRH/primarily devices)
- Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- Unapproved Drugs - Guidance Compliance and Regulatory Information
- Warnings/Untitled Letters
International Health Authority Websites by Country:
- Australia - Pharmaceutical Benefits Scheme (PBS)
- Austria - Austrian Agency for Health and Food Safety
- Canada - Health Canada
- Colombia - Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
- Denmark - Danish Medicines Agency
- Finland - National Agency for Medicines
- France - Agence française de sécurité sanitaire des produits de santé
- Hungary National Institut of Pharmacy
- Ireland - Irish Medicines Board
- Iceland - Icelandic Medicines Control Agency
- Israel - Ministry of Health
- Japan - Pharmaceuticals and Medical Devices Agency (PMDA) & Japan Pharmacists Education Center (JPEC)
- Latvia - State Agency of Medicines of Latvia
- Lithuania - State Medicines Control Agency
- Malta - Malta Medicines Authority
- Netherlands - Medicines Evaluation Board
- New Zealand - Medicines and Medical Device Safety Authority
- Portugal - Instituto Nacional da Farmácia e do Medicamento
- U.K. - Medicines and Healthcare products Regulatory Agency
- Czech Republic - State Institut für Drug Control
- Spain - Agencia Española de Medicamentos y Productos Sanitarios
- Sweden - Medical Products Agency
- Switzerland - Arzneimittel-Kompendium der Schweiz
- USA - U.S. Food and Drug Administration (FDA)
Last Updated June 6, 2011