OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy
FDA Law
AUGUST 16, 2023
Prior to the CytoDyn letter in 2022, OPDP issued a Warning Letter in 2021 to CooperSurgical for a DTC video entitled “Paragard: Family Planning During the Pandemic” which failed to communicate ANY risk information. The claims are (presumably) not made to patients and each had context that described how the data was interpreted.
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