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FDA Delays Moderna Adolescent Vaccine EUA: Reports

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FDA delays its decision on expanding a Moderna emergency use authorization for its Covid-19 vaccine in adolescents while it furthe...

FDA Needs Regulatory Competitiveness Official: ex-FDAer

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Former FDA associate commissioner Peter Pitts says FDA needs a deputy commissioner for regulatory competitiveness to aggressively ...

FDA Update on Heater-Cooler Device Infections

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FDA provides an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria infections i...

Genentechs Tecentriq Approved for Stage 2-3a Lung Cancer

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FDA approves Genentechs Tecentriq (atezolizumab) as an add-on treatment following surgery and platinum-based chemotherapy for adul...

FDA Oversteps on Robot Surgery Devices: Attorneys

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Two Hyman, Phelps & McNamara attorneys take issue with FDAs new approach to regulate novel robot assisted surgery devices for spec...

CDRH Digital Transformation Initiative Updated

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CDRH director Jeffrey Shuren and Office of Product Evaluation and Quality director William Maisel describe initiatives under the C...

FDA Denies Staple, Staplers, and Mesh Petitions

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FDA denies three petitions asking it to require manufacturers of surgical staplers and staples to provide performance data on the ...

Teligent Recalls 5 Topical Lidocaine Lots

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Teligent Pharma recalls five lots of lidocaine HCl Topical Solution 4%, 50ml in screw cap glass bottles after a stability sample w...

Regeneron Seeks Approval for Covid Therapy

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FDA accepts for priority review a Regeneron Pharmaceuticals BLA for Regen-Cov (casirivimab and imdevimab) for treating Covid-19 in...

Drug Distribution Security Public Meeting

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Federal Register notice: FDA announces an 11/16 virtual public meeting entitled Enhanced Drug Distribution Security at the Package...