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Guide on Devices Opioid Use Disorder

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Clinical Considerations for Studies of Devices Intended to ...

UltraSight Ultrasound Guidance Software Cleared

[ Price : $8.95]

FDA clears an UltraSight 510(k) for its artificial intelligence-powered ultrasound guidance technology.

Contact Lens Care Product Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Hydrogen Peroxide-Based Contact Lens Care Products: Consume...

Guide on Drug Quality Consensus Standards

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled CDERs Program for the Recognition of Voluntary Consensus St...

Opioid Disorder Innovative Devices

[ Price : $8.95]

FDA issues a draft guidance to help sponsors design pivotal clinical trials for innovative medical devices to treat opioid use dis...

Compliance Woes at Wegovy Syringe Plant

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Reuters says FDA documents show sterility issues at the Catalent facility in Brussels, Belgium, that fills Wegovy syringes for Nov...

FDA Wont Review Toriluzole NDA

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FDA says it wont review the BioHaven NDA for toriluzole to treat spinocerebellar ataxia because a Phase 3 trial did not meet its p...

RFK, Jr. for FDA or CDC: DeSantis

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Florida governor Ron DeSantis says that if he is elected president he might name avowed anti-vaxxer Robert F. Kennedy, Jr., to hea...

Drug Shortage Legislative Fix Introduced

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Sen. Gary Peters introduces bipartisan legislation he says will help ease drug shortages by requiring HHS to award contracts that ...

Abiomed Impella Pump Recall

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Abiomed recalls its Impella Left Sided Blood Pumps because the devices Instructions for Use do not adequately address precautions ...