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FDA Not Yet Implementing OTC Drug Reforms: GAO

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A Government Accountability Office review of FDAs over-the-counter drug monograph program performance finds that the agency has no...

Info Collection on Device Improvement Program

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Federal Register notice: FDA sends to OMB a new medical device-related information collection entitled Voluntary Improvement Progr...

Guide on Devices Opioid Use Disorder

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Federal Register notice: FDA makes available a draft guidance entitled Clinical Considerations for Studies of Devices Intended to ...

Opioid Disorder Innovative Devices

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FDA issues a draft guidance to help sponsors design pivotal clinical trials for innovative medical devices to treat opioid use dis...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

Merck Pneumococcal Vaccine Hits Phase 3 Marks

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Merck says its investigational V116 21-valent pneumococcal conjugate vaccine hit key immunogenicity and safety endpoints in two Ph...