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 $6.4 billion accord for U.S. drug and device reviews is set to unravel just three months after taking effect as lawmakers squabble over budget cutbacks. Drug reviews, which rely heavily on fees paid by companies, may slow or halt in January because the FDA must receive certain funding from Congress before it can spend any of the industry money, said Karen Riley, an FDA spokeswoman. Bloomberg