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.
The FDA has approved Auxilium Pharmaceuticals’ Xiaflex biologic injection for Peyronie’s disease, a deformity of the penis caused by a lump of plaque that results in a curvature of at least 30 degrees.
The FTC is challenging a GlaxoSmithKline (GSK)-Teva patent settlement deal, filing an amicus brief that argues authorized generic agreements fall under the category of pay-for-delay deals and are anticompetitive. The FTC wants the U.S. District Court for the District of New Jersey to adopt the 3rd Circuit Court of Appeals’ recent ruling in K-Dur, and it argues that ruling effectively declared authorized generic deals illegal. Drug Industry Daily