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 drug does not have a Boxed Warning, but has an extensive list of Warnings (17 in total).
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