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, noted
attorneys Ivan J. Wasserman and Stephen A. Wood
with Kelley Drye & Warren, offer professional guidance on these two choices
for your device approval, and how they fit into your risk management plan.