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 FDA’s Office of International Programs (OIP) is exploring development of a single, global recall system that would encompass all domestic and international recalls. The move toward a global system, currently in its early stages, would help address fast-growing gaps in global oversight of international product recalls, Mark Roh, regional food and drug director for the FDA’s Pacific Region, said. Drug Industry Daily