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.
Stryker Orthopaedics is facing a lawsuit alleging damages caused by the company’s titanium alloy Rejuvenate hip system. The suit, filed Aug. 7 in the Superior Court of New Jersey, claims that a Florida woman, Dianne Pingel, received two Rejuvenate hips in October 2011 and suffered a femur fracture while undergoing revision surgery after one of the implants failed. The GMP Letter