Now showing items 1-2 of 2
Economic return of clinical trials performed under the pediatric exclusivity program.
CONTEXT: 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 ...
Spending on postapproval drug safety.
(Health Aff (Millwood), 2006-03)
Withdrawals of high-profile pharmaceuticals have focused attention on post-approval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding ...