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DexCom Alert on Stolen Glucose Monitoring Sensors

[ Price : $8.95]

DexCom says it has identified two lots of stolen Dexcom G7 continuous glucose monitoring sensors that were diverted into the comme...

Drug User Fee Agreement Now Faces Political Debate

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FDA and the drug industry conclude technical negotiations over the next iteration of the Prescription Drug User Fee Act, setting t...

FDA Drug Ad Crackdown Leads to More Spending on TV/Streaming Ads: Report

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An FDA crackdown on allegedly deceptive prescription drug advertising leads to a sharp increase in pharmaceutical advertising spen...

Medical Device Human Factors Info Submission Guidance

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FDA publishes a final guidance to assist sponsors in submitting human factors information with medical device marketing applicatio...

2 Bioequivalence Guidances Published

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FDA publishes two final guidances on aspects of establishing bioequivalence.

Change FDA Sepsis Screening Strategy: Dingell and McCormick

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Reps. Debbie Dingell and Rich McCormick say FDA should update its strategy for evaluating and identifying sepsis as a means to exc...

FDA Marks 50th Anniversary of Device Amendments

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FDA marks the 50th anniversary of the 1976 Medical Device Amendments by highlighting the laws lasting role in shaping the modern o...

FDA Updates Phillips Trilogy Ventilator Corrections

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FDA issues an update on a Philips Respironics device correction involving its Trilogy Evo platform ventilators, citing risks that ...

Berens Infantile Niemann-Pick disease Drug Review Extended

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FDA extends by three months its review timeline of a Beren Therapeutics NDA for adrabetadex for treating infantile-onset Niemann-P...

Imfinzi Get Expanded Use in High-Risk Bladder Cancer

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FDA approves AstraZenecas Imfinzi (durvalumab) in combination with Bacillus Calmette-Guerin (BCG) for treating adults with BCG-nav...