FDA complete response letters can also tell you if the bet you've made in your company's future is likely to pay off. For example, if XYZ Pharma was hyping an upcoming cholesterol drug that would ...
Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.
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DexCom Gets FDA Warning Letter After Inspections of FacilitiesDexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.
James Jones resigned as FDA deputy commissioner and said the Trump administration's "indiscriminate" job cuts show "disdain for the very people necessary to implement your agenda." ...
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 said that on Tuesday it received a warning letter from the U.S. FDA following inspections ... manufacturing processes and quality management systems. The FDA cited issues with DexCom's response ...
The company expanded its drug's use to pediatric patients for EDS with narcolepsy last year but received a complete response letter in response to its bid for a pediatric cataplexy approval.
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