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OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy

FDA Law Blog

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. Let’s go over some background information relating to Breztri and the OPDP Warning Letter.

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Analysis of primary care prescription trends in England during the COVID-19 pandemic compared against a predictive model

BMJ

By John Scott Frazer, Glenn Ross Frazer Reference : Frazer JS , Frazer GR, Analysis of primary care prescription trends in England during the COVID-19 pandemic compared against a predictive model, Family Medicine and Community Health 2021; 9: e001143.