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Hutchmed NDA for Colorectal Cancer Drug

[ Price : $8.95]

Hutchmed Ltd. completes a rolling NDA submission for fruquintinib, described as a highly selective and potent oral inhibitor of VE...

Draft Guide Non-IRB Approvable Child Research

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Research Involving Children as Subjects and Not Otherwise A...

Guide on Harmonized Medicinal Product Identification

[ Price : $8.95]

FDA posts a final guidance entitled Identification of Medicinal Products Implementation and Use based on five ISO standards.

Prescription Drug Advertising Info Collection

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Prescription Drug Advertising.

U.S. Government Sides with Generics in Labeling Case

[ Price : $8.95]

A U.S. government amicus brief sides with the generic drug industry in a closely watched Supreme Court appeal of a skinny label ca...

Datascope Recalls Cardiosave and Hybrid Pumps

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Datascope recalls its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps due to an internal communication loss that could cau...

Panel to Discuss Rexulti for Alzheimers Agitation

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Federal Register notice: FDA announces a 4/14 joint advisory committee meeting to discuss an Otsuka Pharmaceutical and Lundbeck su...

FDA Evaluating Adult Dental Device Concerns

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FDA says it is evaluating safety concerns with the use of some fixed palatal expander devices in adults to remodel the jaw or addr...

Midwest Vet Supply Forfeits $10 Million for Misbranding

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Midwest Veterinary Supply agrees to pay more than $10 million in forfeiture and fines as part of a plea agreement for misbranding ...

AI/ML Software Marketing Submission Guidance

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FDA publishes a draft guidance recommending the information to be included in a predetermined change control plan in a marketing s...