Archive for July, 2010
FDA and Lifestyle Drugs — The Next Chapter in the Story
For those who may have missed the news from last week, Vivus Pharmaceuticals missed big time with Qnexa. Their FDA Endocrinologic and Metabolic Drugs advisory committee voted against recommending the anti-obesity drug for approval, basing their decision primarily on the absence of long-term safety data. The committee vote was 10 to 6 against approval. A comment made [...]
Technical Communication Myths
My colleague Jessica Mahajan came across this post on the blog TechCommDood talking about common technical communication myths. Myths that apply to medical writing as well.
FDA and Lifestyle Drugs….Drawing a Line?
The winds at FDA appear to be shifting direction when it comes to “lifestyle” drugs. The mood surrounding lifestyle drugs in FDA Advisory Committees suggests the approval bar may have been moved somewhere closer to the neighborhood of infinity.
Now I want to be clear that the precise definition of lifestyle drugs is a subject of [...]