Medical Device Network on MSN2d
Analysts say Dexcom’s FDA warning unlikely to impact 2025 revenue
Dexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...
DexCom Stock Drops as Diabetes Devices Maker Gets FDA Warning Letter
DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants.
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FDA goes digital with eServices Portal System
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...
Dexcom receives FDA warning letter for two U.S. manufacturing facilities
The warning letter identified issues in manufacturing processes and quality management system at Dexcom's facilities in San ...
The Print on MSN1d
Top pharma alliance refutes ‘ill-researched’ US study linking Indian generics to higher adverse events
Indian Pharmaceutical Alliance says the study relies on FDA Adverse Event Reporting System data, which captures link between ...
DexCom falls after warning letter from FDA related to quality concerns
The FDA cited issues with DexCom’s response to prior inspection findings, known as Form 483 observations. The inspections took place at the San Diego facility between October 21 and November 7, 2024, ...
Access to Compounded GLP-1s Is Drying Up. Here’s What to Know About the Copycat Weight-Loss Drugs.
To be a person in the year 2025 is to encounter, in one way or another, the marketing onslaught for compounded ...
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Dexcom receives warning letter based on FDA inspections of 2 plants
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
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DexCom falls after warning letter from FDA related to quality concerns
and Mesa, Ariz. related to concerns about manufacturing processes and quality management systems. The FDA cited issues with DexCom's response to prior inspection findings, known as Form 483 ...
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Testing the Future: Redefining QA for AI and ML Systems
In the fast-evolving world of artificial intelligence and machine learning, the importance of rigorous quality assurance ...
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Over 1.2 million medical device side-effect reports not submitted within legal timeframe
Over 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data ...
News Medical on MSN2d
How the FDA opens the door to risky chemicals in America’s food supply
The FDA’s restraints on food ingredients are limited and relatively feeble, especially compared with those in Europe, a KFF Health News examination found.