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)

Guidance, Compliance and Regulatory Information (Biologics)

• Guidance, Compliance & Regulatory Information (Biologics)