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Lupin Pharma Recalls Irbesartan Over Impurity

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Lupin recalls all irbesartan and irbesartan/hydrochlorothiazide tablets after finding some active pharmaceutical ingredient batche...

Vaccine Panel Backs J&J Booster Vaccine

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An FDA advisory committee unanimously votes to recommend Johnson & Johnsons Covid-19 booster vaccine in all adults two months afte...

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...

Califf May Return as FDA Commissioner: Report

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The Washington Post says three sources have indicated the Biden administration is close to bringing former FDA commissioner Robert...

Abbott Molecular Alinity Covid Kit Recall is Class 1

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FDA says the Abbott Molecular recall of two SARS-CoV-2 test kits is Class 1.

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...