CytoDyn’s Promotion Of Investigational Drug Leronlimab Once Again Rebuked By US FDA
OPDP warning letter objects to video interview in which CytoDyn's then CEO touts use of the investigational drug for COVID-19. The exec says he is ‘making up numbers’ but if the pattern continues there will be ‘the most fantastic results’ anybody could ever imagine.
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Warning letter is first issued by US FDA’s Office of Prescription Drug Promotion in more than a year and only the seventh since March 2020, continuing a trend away from using the enforcement tool. AstraZeneca asked to distribute corrective communications about pamphlet’s efficacy claims.
Careful identification and vetting of spokespersons, training on FDA regulations, and development of content that conveys the typical patient experience are keys to successful and compliant influencer campaigns, advertising, legal and regulatory experts told a recent DIA conference.
Keeping Track: Gilead Gets CRL For Bulevirtide, CytoDyn Withdraws Leronlimab; Eye and CNS Drug Submissions
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker