FDA: Wyeth's DTC for ReFacto has unsubstantiated safety claims

A Wyeth Pharmaceuticals direct-to-consumer brochure for ReFacto antihemophilic factor contains unsubstantiated safety claims, according to an FDA notice of violation letter. The brochure, titled “Bob's World,” contained a “Pathogen Safety” sub-section claiming state-of-the-art manufacturing techniques to optimize pathogen safety.
You must be a registered member of MMM to post a comment.
close

Next Article in Pharmaceutical

 

Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.