OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy
FDA Law Blog
AUGUST 16, 2023
In this most recent Warning Letter, however, OPDP did not take issue with ANY of the safety information presented about Breztri in the sales aid; rather, objections were focused solely on false or misleading claims related to efficacy. OPDP first took issue with a headline and graph presented on page 7 of the 12-page brochure.
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