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.
Through its licensing partner, AngioDynamics, IBI has just cleared a major regulatory hurdle that will allow a medical device using its polymer-based additives to be used in the United States. Medical Xpress