Now showing items 1-6 of 6
Does generic entry always increase consumer welfare?
(Food Drug Law J, 2012)
This article examines how the nature of competition between brands in a therapeutic category changes after generic entry and provide a framework for analyzing the effect of generic entry on consumer welfare that takes into ...
The cost of drug development.
(N Engl J Med, 2015-05-14)
Economics of new oncology drug development.
(J Clin Oncol, 2007-01-10)
PURPOSE: Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. METHODS: We utilized data from the US Food and Drug Administration (FDA), company ...
Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future.
(Health Aff (Millwood), 2014-06)
In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing ...
Should the patent system for new medicines be abolished?
(Clin Pharmacol Ther, 2007-11)
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 ...