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 Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert for GE Healthcare’s Auxiliary Common Gas Outlet (ACGO). An incorrect setting of the ACGO switch will result in no fresh gas flow to the patient. Furthermore, if the circle breathing circuit is incorrectly attached to the ACGO, this may result in barotrauma.