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.
Clinical trial sponsors could have an easier time qualifying trial sites and training investigators as a new Big Pharma initiative aims to standardize these procedures and support mutual recognition of qualification and training. Ten pharma giants have formed the nonprofit TransCelerate BioPharma to speed development of new medicines. Drug Industry Daily