Opioid Warning Letter To Cipher Likely Easy Call For US FDA
Murky enforcement environment has probably contributed to FDA's record-low number of letters, but detailing material for ConZip failed to include risk information and important limitations of use for the tramadol extended-release product.
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Last year's record low five letters came as FDA launched flurry of studies on DTC, professional ads; 'Bad Ad' complaints totaled more than 100.
Warning letter objects to webpage and meeting exhibit material for excluding any risk information and suggesting mist formulation is superior to oral zolpidem products.
Agency seeks long-acting opioid’s withdrawal due to evidence the reformulated version increased intravenous abuse; FDA’s action, which Endo is weighing, portends a hard-line stance when it comes to opioid risks under new Commissioner Scott Gottlieb.