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Medical Devices

Medical Device Reports Updated on Bayers Essure

FDA updates its Web site to include an annual analysis of medical device reports involving Bayers now-withdrawn Essure contraceptive implant that were...

Biologics

More European Countries Temporarily Suspend Vaccine

More European countries announce a temporary suspension on administering AstraZenecas Covid-19 vaccine due to concerns about reports of blood clots in...

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 3/12/2021.

Federal Register

VistaPharm Not Withdrawing 2 ANDAs

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

Federal Register

Sarepta Therapeutics Wins Priority Review Voucher

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

Federal Register

FDA Withdraws 5 Bacitracin ANDAs

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

Medical Devices

Roche Covid/Influenza Assay False Positives: FDA

FDA alerts health care providers and laboratory staff about false positive results which can occur with the Roche Molecular Systems cobas SARS-CoV-2 a...

Medical Devices

Combat Medical Recalls Convenience Kits

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

Human Drugs

Marius Pharmaceuticals Testosterone NDA Accepted

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

Biologics

AstraZeneca Nearing EUA Request for Covid Vaccine

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