What’s New for Biologics
Wed Jan 14 11:35 am
FDA | What's New: Vaccines
Drugs@FDA Data Files
Wed Jan 14 10:28 am
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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Artificial Intelligence for Drug Development
Wed Jan 14 9:44 am
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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Guiding Principles of Good AI Practice in Drug Development
Wed Jan 14 9:44 am
CDER and CBER have collaborated with the European Medicines Agency (EMA) to develop 10 guiding principles that industry and product developers can consider when using artificial intelligence (AI) to advance drug and biological product development.
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Biologics Electronic Reading Room (eFOIA)
Tue Jan 13 5:00 pm
The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.
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PREA Non-Compliance Letters
Tue Jan 13 9:21 am
Recently Issued Guidance Documents
Mon Jan 12 3:39 pm
Clinical Guidances
Mon Jan 12 3:38 pm
FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation
Sun Jan 11 3:03 pm
The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT).
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Cellular & Gene Therapy Products
Sun Jan 11 2:58 pm
CBER provides oversight of clinical studies, proactive scientific and regulatory advice to medical researchers and manufacturers of cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy.
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2026 Safety and Availability Communications
Fri Jan 09 9:32 pm
Safety & Availability (Biologics)
Fri Jan 09 5:37 pm