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Medical Device Reports Updated on Bayers Essure

[ Price : $8.95]

FDA updates its Web site to include an annual analysis of medical device reports involving Bayers now-withdrawn Essure contracepti...

More European Countries Temporarily Suspend Vaccine

[ Price : $8.95]

More European countries announce a temporary suspension on administering AstraZenecas Covid-19 vaccine due to concerns about repor...

VistaPharm Not Withdrawing 2 ANDAs

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Federal Register notice: FDA corrects a 12/11/2020 notice that announced the withdrawal of of 10 ANDAs from multiple applicants.

Sarepta Therapeutics Wins Priority Review Voucher

[ Price : $8.95]

Federal Register notice: FDA issues a priority review voucher to Sarepta Therapeutics for a qualifying rare pediatric disease prod...

FDA Withdraws 5 Bacitracin ANDAs

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Federal Register notice: FDA withdraws approval of five Bacitracin for injection ANDAs from multiple holders Akorn, Mylan, Pfizer...

Roche Covid/Influenza Assay False Positives: FDA

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FDA alerts health care providers and laboratory staff about false positive results which can occur with the Roche Molecular System...

Combat Medical Recalls Convenience Kits

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Combat Medical Systems recalls its Valkyrie LTOWB Collection, Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion Set,...

Marius Pharmaceuticals Testosterone NDA Accepted

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FDA accepts for review a Marius Pharmaceuticals NDA for Kyzatrex (oral testosterone undecanoate) for primary and secondary male hy...

AstraZeneca Nearing EUA Request for Covid Vaccine

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AstraZeneca plans to seek an emergency use authorization for its Covid-19 vaccine by early April after determining that it has met...

FDA Clears Baxter Next-Gen Dialysis Machine

[ Price : $8.95]

FDA clears a Baxter International 510(k) for its next-generation Artificial Kidney 98 (AK 98) dialysis machine, which is designed ...