If drug tariffs don’t work, they could result in higher prices for American patients and increase drug shortages. Testing ...
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
DexCom said that on Tuesday it received a warning letter from the U.S. FDA following inspections at its facilities in San ...
Key Takeaways DexCom received a warning letter from the Food and Drug Administration following inspections of two of its ...
Dublin, Feb. 25, 2025 (GLOBE NEWSWIRE) -- The "What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Records Explained" training has been added to ResearchAndMarkets.com's offering.
Medical Device Network on MSN4d
Analysts say Dexcom’s FDA warning unlikely to impact 2025 revenueDexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device ...
The Trump Administration reversed course on plans to terminate the lease of a major Food and Drug Administration quality lab ...
In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...
Dexcom: The company did not provide details about how many observations were made at the two sites, but said it does not ...
along with the applicable quality management systems. Imricor is executing a modular review process with the FDA, whereby ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results
Feedback