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In this section: Vaccines, Blood & Biologics

CBER Reports

CBER Reports are a summary of regulatory, research, and administrative accomplishments for the last 2 fiscal years and related reports.

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CY 2024 Report from the Director

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FDA Report to Congress: Least Burdensome Training Audit

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FDA Report to Congress: Least Burdensome Training Audit Addendum

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User Fee Billable Biologic Products and Potencies Approved Under Section 351 of…

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Biologics PREA Reviews and Labeling Changes

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PREA Non-Compliance Letters

CY 2023 Report from the Director

FY 2020 Report from the Director

FY 2019 Report from the Director

FY 2018 Report from the Director

FY 2017 Report from the Director

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Real-World Evidence Submissions to CBER

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Fast Track Designation Request Performance

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