FDAAA Pays Off: Drug Safety Controls Bring Immediate Returns to Sponsors

Companies as diverse as CV Therapeutics, UCB, GSK, Pozen and Biovail are all smiles about becoming unwitting guinea pigs in the new era of drug safety. None could have expected to be pioneers in facing new post-marketing burdens-but all are thrilled that their products were approved at all. And most have seen an immediate payback for their investors.