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.
Boehringer Ingelheim Pharmaceuticals, Inc. announced Nov. 7 that it is conducting a nationwide voluntary recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate). Healthcare Packaging