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Bayesian Statistical Analysis Demonstration Project

[ Price : $8.95]

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...

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 ...