Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement Staff draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.
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Antibody Glycosylation Insights for High-Quality Biotherapeutics
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Listing of the 2025 Biological License Application Supplement Noteworthy Approvals
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Listing of the 2025 Biological License Application Approvals
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This page lists Recently Issued CBER and Cross-Center Guidance Documents.
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This page lists Administrative Guidance documents.
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History of all updates to the application software in reverse chronological order by version number
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Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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The Laboratory Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used as an agency policy for testing consumer products, training of laboratory staff, report writing, safety, research, review of private laboratory reports and cour
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Latest news from the Center for Biologics Evaluation and Research
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These Standard Operating Procedures and Policies (SOPPs) are used by staff in FDA's Center for Biologics Research and Review (CBER) in the performance of their duties. They are made available here to the public because CBER is committed to being as transparent as possible in how it operates.
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FDA recognizes the increased use of AI throughout the drug development process and across a range of therapeutic areas. Learn more.
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