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FDA General

No Rush on FDA Nomination: HHS Secretary

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

Medical Devices

NeuraLace Magnetic Stimulator for Pain Cleared

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

Marketing

Hard to Isolate Drug Ad/Medicare Spend Relationship: GAO

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

Medical Devices

CDRH Seeks Input on Cybersecurity Servicing Practices

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

Medical Devices

Lawmakers Urge FDA to Prioritize T Cell Covid Tests

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

Human Drugs

Tyvaso DPI Pulmonary Hypertension NDA Accepted

FDA accepts for priority review a United Therapeutics NDA for Tyvaso DPI (inhaled treprostinil) for treating pulmonary arterial hypertension.

Human Drugs

Woodcock, 2 Others Must Go Over Aducanumab: Public Citizen

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

Medical Devices

Class 1 Recall of Alaris Pump Bezels

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

Human Drugs

No Change in Risk/Benefit Analysis: Cavazzoni

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

Human Drugs

Industry MIDD Paired Meeting Program Benefits Cited

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