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Quarter 3 Drug and Device Recalled Units Higher: Sedgwick Index

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The Sedgwick third-quarter recall index sees a sharp increase in the number of affected drug and medical device units.

Prasad Defends Vaccine Policy Shift: Report

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CBER director Vinay Prasad addresses a 12/4 investor conference in New York and defends his leadership, and attributing criticism ...

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...