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.
Respironics’ Trilogy 100, 200 and 202 ventilators are being recalled because of defects in their power supply components. If the power supply stops, a ventilator may abruptly cease functioning. The recall affects ventilators made between Jan. 1 and April 27 of this year. Respironics, which initiated the Class I recall, is asking customers to return the affected products for replacement. The GMP Letter