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.
In this 90-minute audio CD/transcript, Keith Korenchuk, attorney with Covington & Burling, LLP, Ron Buzzeo, chief regulatory officer, Dendrite International, and Paul Silver, managing director, Huron Consulting Group, team up to give you strategies to navigate this new regulatory minefield.