Now showing items 1-6 of 6
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)
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 ...
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 ...