Li, Jennifer. S; Eisenstein, Eric Leo; Grabowski, Henry G.; Reid, Elizabeth. D; Mangum, Barry; Schulman, Kevin Alan; Goldsmith, John V.; Murphy, M. Dianne; Califf, Robert M.; Benjamin, Daniel Kelly Jr.
(2007-02-07)
In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric trials. ...