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CDER Compliance Chief Details Compliance Shifts

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CDER Office of Compliance director Jill Furman highlights a year of sweeping operational shifts, heightened enforcement, and emerg...

Biden Admin Buried Covid Myocarditis Data: Makary

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FDA commissioner Marty Makary alleges that the Biden administration failed to disclose internal data on myocarditis risks in young...

Political Interference Prompted Pazdur Retirement: Peter Pitts

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Former FDA associate commissioner Peter Pitts says CDER director Richard Pazdurs decision to abruptly retire was motivated by grow...

Capricor Reports Data to Support Rejected Deramioce BLA

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Capricor Therapeutics says Deramiocel, a cell therapy candidate targeting cardiomyopathy associated with Duchenne muscular dystrop...

26 Rare Disease Drug Approvals in 2024: ARC Report

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The CDER Accelerating Rare Disease Cures program Year-Three report shows a decline in new drug approvals and several other activit...

American Hospital Association AI Policy Ideas

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The American Hospital Association suggests ways for FDA to develop a regulatory framework for measuring and evaluating AI-enabled ...

FDA Blocks Lawmakers from Attending Cancer Drug Meeting

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A new Bloomberg report finds that two Republican lawmakers were barred from attending a 12/3 FDA meeting concerning the potential ...

FDA Grants Full Approval to Lillys Jaypirca

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FDA awards Eli Lilly traditional approval for Jaypirca (pirtobrutinib) and its use in adults with relapsed or refractory chronic l...

Integrate Key Teams for CNPV Success: Expert

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Veristat principal regulatory specialist John Kirk outlines FDAs Commissioners National Priority Voucher program and how sponsors ...

FDA Taps Tracy Beth Heg as Acting CDER Director

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FDA names physicianepidemiologist Tracy Beth Heg as CDER acting director, replacing director Richard Pazdur, who submitted his ret...