US FDA Documents – Regulations.gov
US FDA Warning Letters Search Database
US FDA Online Label Repository
US FDA Clinical Trial Database -ClinicalTrials.gov
US FDA Advisory Committee Meetings
US FDA Inspections Classification Database
Drugs
· Center for Drug Evaluation and Research (CDER)
· Postmarket Drug Safety Information for Patients and Providers
· Prescription Drug User Fee Amendments
· Orange Book -Approved Drug Products with Therapeutic Equivalence Evaluations
· National Drug Code Directory
· Drug Establishment & Current Registration Site
· FDALabel – Labeling Database- Drugs
· FDA Adverse Event Reporting System (FAERS): (AEs associated with drugs & therapeutic biologics)
· MedWatch Safety Alerts for Human Medical Products
Biological Products
· Center for Biologics Evaluation and Research (CBER)
· Biologics Products & Establishments – Listing of Biological Product Approvals and Clearances
· Biosimilar User Fee Amendments
· Biological Approvals by Year
· Purple Book Database of Licensed Biological Products
· Center for Biologics Evaluation and Research (CBER) Product Approval Information
· Compliance Actions (Biologics)
Medical Devices
· Center for Devices and Radiological Health (CDRH)
· Device Product Classification Database
· De Novo (Device) Classification Database
· Medical Device User Fee Amendments (MDUFA)
· Premarket Approval (PMA) database
· MAUDE Database (Manufacturer and User Facility Device Experience)
· Establishment Registration & Device Listing
· Recognized Consensus Standards: Medical Devices
· Global Unique Device Identification Database (GUDID)