A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
An FDA advisory panel voted 12–0 Tuesday to recommend approval of NPS Pharmaceuticals’ Gattex as a treatment for short bowel syndrome. Gattex (teduglutide) achieved its primary endpoint in one of its two clinical trials, attaining at least 20 percent reduction from baseline in parenteral nutrition/intravenous fluid (PN/I.V.). Drug Industry Daily