CBER Reports

CBER Reports older than 2017 are available on FDA Archive.

General

• CY 2023 Report from the Director
• FDA Report to Congress: Least Burdensome Training Audit
• FDA Report to Congress: Least Burdensome Training Audit Addendum
• FY 2020 Report from the Director (Archived)
• FY 2019 Report from the Director (Archived)
• FY 2018 Report from the Director (Archived)
• FY 2017 Report from the Director (Archived)
• User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
• Biologics PREA Reviews and Labeling Changes
• PREA Non-Compliance Letters

Biologics Performance Reports

• Real-World Evidence Submissions to the Center for Biologics Evaluation and Research
• Fast Track Designation Request Performance
• Demographic Yearly Data Summaries