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.
CardioComm Solutions submitted an application with the FDA for clearance of its GUAVATM II ECG viewer technology. GUAVATM is a medical software device with a formal application programming interface (API). As an API, it can be incorporated and invoked from host applications to provide services for capturing, storing, retrieving, viewing, editing and analyzing electrocardiogram. Financial Post