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.
Establishing the right kind of verification process and bringing in human factor testing experts early in the development phase are key to successful device design, says industry guru Michael Hoffman. Speaking at an Association for the Advancement of Medical Instrumentation (AAMI) webinar, he described a four-step approach to meaningful design input: translation, implementation, evaluation and evolution. The GMP Letter