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CBER’s Policies, Procedures, and Review Resources
This webpage provides important resources related to the regulatory framework of products regulated by CBER, including policies, procedures, and review resources.
CBER reviews applications for new products, new indications for already approved products, and product-related changes. This requires evaluating submitted scientific and clinical data to determine whether the product meets CBER’s standards for approval. After a thorough assessment of the data, CBER makes a decision based on the risk-benefit for the intended population and the product’s intended use. CBER’s authority resides in the Public Health Service Act and in specific sections of the Food Drug and Cosmetic Act.
Beginning June 12, 2023, CDER and CBER will expand in-person FTF industry meetings (with a hybrid component), to include requests for Type B End-of-Phase 2 (EOP2), along with the previously announced Type A, BPD Type 1, and Type X meeting requests. FTF meeting requests for other meeting types, if granted, will be held fully virtually (i.e., the in-person format will not be considered). Existing meeting requests received before June 12, 2023, or meetings already scheduled regardless of the scheduled meeting date, will not be converted to the in-person format, to permit fair implementation of the transition. For more information, please visit Update on In-Person Face-to-Face Formal Meetings with FDA. For general questions, please contact industry.biologics@fda.hhs.gov.
For detailed information on how to request a meeting with CBER and to find guidance on meeting request content, please visit Formal Meetings for CBER-Regulated Products | FDA.
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Content current as of:
03/25/2025
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Regulated Product(s)
Health Topic(s)
