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.
A New Jersey federal judge on Friday ordered Merck & Co. to hand over purportedly privileged documents produced for government investigations concerning Vioxx — a partial discovery win for multidistrict litigation plaintiffs accusing the company of inflating its stock through misrepresentations about the recalled arthritis medication. Law360