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FDA Approval Process Hurts Device Innovation: Study

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Harvard Business School professor Ariel Stern says that the FDA medical device approval process slows development of innovative ne...

FDA Priority Review for Sarepta Duchenne NDA

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FDA accepts for review a Sarepta Therapeutics NDA for eteplirsen for treating Duchenne muscular dystrophy amenable to exon 51 skip...

Teleflex Medical Recalls Endobronchial Tube

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Teleflex Medical begins a Class 1 recall of its Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube because the devices connector...

Novacare Recalls Potentially Harmful Dietary Supplements

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Murray, UT-based Novacare recalls a number of weight loss-related dietary supplements after sample analyses by FDA revealed that t...

FDA Submits Device Reporting Info to OMB

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Federal Register Notice: FDA submits a proposed collection of information on medical device reporting to the Office of Management ...

Comments Extended on Quality Metrics Guidance/Meeting

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Federal Register Notice: FDA extends the comment period for a draft guidance on its quality metric program and the corresponding p...

Workshop on IVD Testing for Anticoagulants

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Federal Register Notice: FDA plans a public workshop 10/26: In Vitro Diagnostic Testing for Direct Oral Anticoagulants.

Suggestions to Improve DTC Research on Aging

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AbbVie and Lilly give FDA suggestions on ways to improve a proposed research project on how hearing loss associated with aging aff...

FDA Enforcement Discretion Doesnt Preempt Suit: Court

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A Washington Legal Foundation working paper says a recent appeals court decision risks allowing state law to undermine a Congressi...

Support for FDA Move on Endoscope Contamination

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Stakeholders voice support for an FDA draft guidance on mitigating the risk of cross-contamination in flexible gastrointestinal en...