Tag: OPDP enforcement. Warning Letter

OPDP enforcement. Warning Letter

Regulatory/FDA

OPDP Warning Letter Cites CEO’s COVID Claims in Video for IND

OPDP Warning Letter Cites CEO’s COVID Claims in Video for IND

Feb. 28, 2022 – Comments made in a video interview by CytoDyn Inc.’s former president and CEO suggesting that the investigational new drug (IND) leronlimab provides a clinical benefit for those who have COVID-19 were the subject of the FDA Office of Prescription Drug Promotion’s (OPDP’s) first Warning Letter of 2022. “The video makes conclusory […]

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