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FDA Corrects Notice on ANDA Withdrawals

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Federal Register notice: FDA corrects an 11/21/2022 notice that announced the approval withdrawals of 10 ANDAs from multiple appli...

Attorneys Dismiss Hype on FDORA Animal Testing Provision

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Hyman Phelps & McNamara attorneys Mark Tobolowsky and Charles Raver say a recent legislative change on preclinical animal testing ...

Man Fakes Cancer to Skip FDA Misbranding Trial

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An FDA criminal case involving a Mays Landing, NJ, man who marketed a toxic chemical as a weight-loss drug online has led to a gui...

FDA Clinical Hold on 4D Molecular Fabry Drug

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FDA places a clinical hold on 4D Molecular Therapeutics 4D-310 drug therapy being studied for treating Fabry Disease Cardiomyopath...

Annual Postmarketing Requirements Report Posted

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Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Co...

Device Conformity Assessment Pilot Becoming Permanent

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CDRHs Accreditation Scheme For Conformity Assessment pilot program transitions to a permanent program based on review efficiencie...

GSKs Oral Anemia Drug Approved for Dialysis

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FDA approves a GlaxoSmithKline NDA for Jesduvroq (daprodustat) tablet that it describes as the first oral treatment for anemia cau...

Greenleaf Health Hires 2 Former FDA Officials

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Regulatory consulting firm Greenleaf Health brings onboard two former FDA officials former Office of Compliance Don Ashley and fo...

FDA Warning, Import Alert on Contaminated Eyedrops

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FDA issues an import alert and a safety alert on EzriCare Artificial Tears or Delsam Pharmas Artificial Tears due to potential bac...

Philips BiPAP, CPAP Mask Recall is Class 1: FDA

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FDA says the Philips Respironics recall of specified BiPAP and CPAP masks for a safety concern was Class 1