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.
Saint Louis University sued a Medtronic subsidiary in Missouri federal court for allegedly shortchanging the university of more than $7 million in royalty payments for surgical navigation technology products, saying the total damages could be significantly more. Law360