CEL-SCI Warning Letter Shows Pitfalls Of Website Presentations Of Investigational Drugs
This article was originally published in The Pink Sheet Daily
Website suggested that the unapproved cancer immunotherapy was safe and effective, FDA says.
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FDA issues untitled letter to CBA Research Inc. for touting the safety and efficacy of CBT-1 as a cancer therapy on the company website although the agency has yet to complete review of an NDA for the drug.
The institute has come under scrutiny in the past for how it describes its investigational cancer products, but more mainstream oncology companies have also been cited for jumping the gun with promotional claims for products FDA hasn’t yet approved.
The agency sent Validus Pharmaceuticals a letter objecting to web pages that minimize the risk of suicidality with use of the bipolar disorder drug and suggest it does not worsen depression or induce weight gain.