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Covid Drug and Biological Product Development Guidance

[ Price : $8.95]

FDA issues an immediately-in-effect guidance to help sponsors develop drugs and biological products to treat or prevent acute Covi...

No Rush on FDA Nomination: HHS Secretary

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HHS secretary Xavier Becerra says there is no immediate rush to nominate an FDA commissioner and that the agency is fortunate to c...

NeuraLace Magnetic Stimulator for Pain Cleared

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FDA clears a NeuraLace Medical 510(k) for its Axon Therapy for stimulating peripheral nerves and providing chronic nerve pain reli...

Hard to Isolate Drug Ad/Medicare Spend Relationship: GAO

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The Government Accountability Office says Medicare spends almost 60% of its drug budget on products that are advertised to consume...

CDRH Seeks Input on Cybersecurity Servicing Practices

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CDRH releases for comment a discussion paper on cybersecurity practices associated with medical device servicing.

Lawmakers Urge FDA to Prioritize T Cell Covid Tests

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Several Republican members of Congress urge FDA to prioritize tests measuring the presence of T cell-mediated immunity to Covid-19...

Woodcock, 2 Others Must Go Over Aducanumab: Public Citizen

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Public Citizen says FDA acting commissioner Janet Woodcock and two other top agency officials need to resign or be fired for their...

Class 1 Recall of Alaris Pump Bezels

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FDA classifies as Class 1 a recall of the Alaris Infusion Pump Module Model 8100 Bezel, purchased or installed by Infusion Pump Re...

No Change in Risk/Benefit Analysis: Cavazzoni

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CDER director Patrizia Cavazzoni says drug companies and FDA still have progress to make in ensuring diversity and health equity i...

Industry MIDD Paired Meeting Program Benefits Cited

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Industry representatives say the Model-Informed Drug Development paired meeting program started under PDUFA 6 in 2018 should be co...