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 Food and Drug Administration said that it monitored the personal emails of employees who had concerns about unsafe medical devices beginning in April 2010 but said it did so to investigate allegations that the employees had leaked confidential information to the public. The Washington Post