Center for Biologics Evaluation and Research (CBER) | FDA
Aug 15, 2025 · CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and …
Center for Biologics Evaluation and Research - Wikipedia
CBER regulates a number of biologics-related products, including blood tests, computer software, and devices related to blood transfusion, which industry representatives would like to see handled by the …
REGULATORY UPDATE: FDA Releases 2026 CBER Guidance Agenda
4 days ago · The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) released the 2026 guidance agenda on Friday, outlining topics the agency is considering for …
CBER outlines its guidance priorities for 2026 | RAPS
4 days ago · The Center for Biologics Evaluation and Research (CBER) has published a list of the guidances it is considering publishing during 2026. They include guidances on chimeric antigen …
CBER in coordination with OAGS, provides opportunities for small business including: small disadvantaged business, woman-owned small business, veteran-owned small business, service …
FDA is Open to the Idea of Possible Regulatory Flexibility for Cell and ...
3 days ago · The very general potential regulatory flexibilities are not new and have been extended to companies on an individual basis for years. It is encouraging that CBER is appearing to make these …
CBER Approvals: What They Are and Why They Matter
Aug 1, 2025 · When a biological product receives CBER approval, it signals that the product has undergone scientific scrutiny and meets regulatory benchmarks. This assurance allows patients and …
Center for Biologics Evaluation and Research - Toolkit
The Center for Biologics Evaluation and Research (CBER) is the Center within the U.S. Food and Drug Administration (FDA) that regulates certain categories of biologics for human use.
FDA Center for Biologics Evaluation and Research (CBER)
The Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration's (FDA) regulates a variety of products, and verifies or enforces requirements at the time the products …
FDA removes barriers to cell, gene therapy development
4 days ago · FDA wants to exert regulatory flexibility on cell and gene therapies in an effort to bring them to patients more quickly and efficiently.