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Ways to Improve FDA Advisory Committee Process

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Harvard Medical School researchers suggest three ways FDA could improve its use of advisory committees.

FDA Updates eMDR System Enhancements

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FDA updates a Web page with enhancements to the CDRH electronic medical device reporting system.

MDIC Somatic Reference Samples Initiative

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The Medical Device Innovation Consortium launches an initiative to improve the accuracy of next-generation sequencing-based cancer...

Califf on FDA and the Clinical Community

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FDA commissioner Robert Califf discusses the agencys future actions in key priorities including evidence generation and accelerati...

Moderna Seeks EUA for Omicron-targeting Booster

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Moderna submits an EUA for a BA.4/BA.5 Omicron-targeting bivalent booster vaccine that could be available early next month.

Optical Lens Maker Pays $16.4 Million Over False Claims

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Essilor International (Dallas, TX) agrees to pay $16.4 million to resolve allegations that it violated the False Claims Act by pay...

Pfizer/BioNTech Seek EUA for New Booster Vaccine

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Pfizer and BioNTech file a submission seeking FDA Emergency Use Authorization for their booster dose of an Omicron BA.4/BA.5-adapt...

Panel to Vote on Ipsen NDA for Palovarotene

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Federal Register notice: FDA announces a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting.

OMB Approves 11 FDA Info Collections

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Federal Register notice: FDA posts a notification that OMB has approved 11 recent information collections.

CDER to Discuss Quality Management Maturity at Meeting

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CDER plans to review and discuss its proposed Quality Management Maturity program at an 11/2 advisory committee meeting.