Quick Guide to Web Resources
CBER Product Approvals/Clearances and Establishments
- CBER's Licensed Products and Establishments
- Allergenics
- CBER Device Pre-Market Approvals (PMAs) and Humanitarian Device Exemptions (HDEs) [devices associated with blood donor testing]
- Vaccines
- More CBER Product Approvals/Clearances and Establishments
Compliance Actions (Biologics)
- Enforcement Actions (CBER)
- Warning Letters
- Untitled Letters (CBER)
- Biological Product Deviations
- Biological Product Deviation Reports Annual Summaries
- Transfusion/Donation Fatalities
- Enforcement Reports
- Suspension Letters, Notice of Intent to Revoke, and HCT/P Orders
- More Compliance Actions (Biologics)
Safety and Availability (CBER Biologics)
- Vaccine Adverse Events
- Recalls (Biologics)
- Counterfeit Medicine
- More Safety and Availability (CBER Biologics)
Development and Approval Process (CBER)
- Investigational New Drug Applications (INDs) for CBER-Regulated Products
- Biologics License Applications (BLA) Process (CBER)
- Premarket Notification 510(k) Process for CBER-Regulated Products
- Premarket Approval (PMA) for CBER-Regulated Products
- New Drug Application (NDA) Process (CBER)
- Regulatory Submissions in Electronic Format for CBER-Regulated Products
- More Development and Approval Process (CBER)