FDA+ roundup: New untitled letter for web ads without risk info; PANDAs and regulatory uncertainty
The FDA’s Office of Prescription Drug Promotion on Tuesday issued its third untitled letter of the year to Eton Pharmaceuticals, arguing that some web ads for its hydrocortisone drug Alkindi Sprinkle are misleading because they don’t include any information on the drug’s risks.
“The sponsored links are misleading because they present claims and/or representations about the use and/or benefits for Alkindi Sprinkle but fail to communicate any risk information,” the letter dated Aug. 9 said.
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