FDA will host Rare Disease Day, a virtual public meeting, on Monday, February 23, 2026 in global observance of Rare Disease Week. The theme is: “Moving Forward. Looking Ahead. An Event for Patients.” The goal of this year’s RDD is to explore ways to engage and collaborate with patients and their communities to support and accelerate the development
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ABECMA is the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
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Latest news from the Center for Biologics Evaluation and Research
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Blood Grouping Regents, BL 101728-34;103292; 125848-125855
Reagent is used for testing human red blood cells by the room temperature saline tube test
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FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028 through 2032. The public meeting will be held on December 3, 2025, from 9 a.m. to 12 p.m ET.
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Learn how to spot health fraud and avoid it.
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A CBER-regulated product shortage occurs when a CBER-regulated product is not commercially available in sufficient quantity to meet the demand.
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This guidance provides, among other things, the standards for a valid eCopy under section 745A(b)(2)(A) of the FD&C Act.
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Advancing Real-World Evidence in FDA Regulatory Decision Making
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Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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This page lists Recently Issued CBER and Cross-Center Guidance Documents.
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This page lists Labeling and Promotion Guidance documents.
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