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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...

Bayesian Statistical Analysis Demonstration Project

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FDA solicits proposals for the CDER Center for Clinical Trial Innovation Bayesian Statistical Analysis demonstration project.

CBER Inspections Challenged by Lack of Facility Readiness

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CBER says that a common deficiency that is driving a significant share of BLA-related complete response letters is manufacturing f...

Clinical Hold Lifted on Vandas Motion Sickness Studies

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FDA lifts a partial clinical hold on one of Vanda Pharmaceuticals key tradipitant studies, clearing the company to expand dosing i...

FDA Alert on Olympus Ligating Device Instructions

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FDA issues a device correction alert after Olympus recalled (Class 1) the instructions for its Single Use Ligating Device PolyLoop...

The Case for FDA Advisory Committees: Column

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provals managing director Steven Cohen lists the many benefits of FDA advisory committees even as the agency has reduced its use o...

Turalio Video Testimonial False or Misleading: OPDP

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The CDER Office of Prescription Drug Promotion says a Daiichi Sankyo promotional video patient testimonial for its Turalio mislead...