This glossary defines terms that will be used in the series of methodological Patient-Focused Drug Development (PFDD) FDA guidance documents that are required by the 21st Century Cures Act, and part of commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Act (PDUFA
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CDER Data Standards Program
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The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions. This helps bring safe and effective products to market.
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This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.
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FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.
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Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
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On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
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Failure to Register and List/Misbranded

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Information related to FDA’s preparation for the seventh reauthorization of PDUFA.
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Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require application holders for certain drugs to make labeling changes based on new safety information. Learn more.
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Information on patents and suitability petitions that impact the availability of generic drugs.
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Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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