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What’s New: FDA Drug News

  • Novel Drug Approvals for 2023
    by FDA on March 22, 2023 at 8:53 pm

    Each year, CDER approves a wide range of new drugs and biological products.

  • CDER Manual of Policies & Procedures | MAPP
    by FDA on March 22, 2023 at 8:38 pm

    CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures.

  • Ongoing | Cancer Accelerated Approvals
    by FDA on March 22, 2023 at 7:56 pm

    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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  • Novel Drug Approvals for 2023 March 22, 2023
    Each year, CDER approves a wide range of new drugs and biological products.
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  • In a surprise approval, FDA green-lights Incyte's PD-1 inhibitor to treat rare cancer type March 22, 2023
    In a surprise approval, FDA green-lights Incyte's PD-1 inhibitor to treat rare cancer type zbecker Wed, 03/22/2023 - 17:30
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