Now showing items 1-3 of 3
Entry and competition in generic biologics
(Managerial and Decision Economics, 2007-06-01)
Patents for several blockbuster biological products are expected to expire soon. The Food and Drug Administration is examining whether biologies can and should be treated like pharmaceuticals with regard to generics. In ...
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 ...