Safety and Efficacy

21
Dec

CP Spurs FDA Decision that Alcohol in Dextrose was Withdrawn for Reason of Safety or Efficacy

In a move not often seen, a Citizen Petition was submitted asking the FDA to make a determination that certain Alcohol and Dextrose injection products were not withdrawn for safety or efficacy (S&E) reasons; In a Federal Register notice (here), the Agency took the opposing view and stated that all Alcohol and Dextrose injection products […]

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