Now showing items 11-20 of 90
Do Faster FDA Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act
times have significantly declined since the passage of PDUFA in 1992, while agency resources have expanded through user fees. After the recent withdrawal of Vioxx and other high-profile products, there have been increasing ...
Do faster food and drug administration drug reviews adversely affect patient safety? An analysis of the 1992 prescription drug user fee act
(Journal of Law and Economics, 2008-05-01)
Food and Drug Administration (FDA) review times have significantly declined under the user-fee regime. This situation has provoked concerns that drug safety has been adversely affected. Combining information from several ...
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 ...
The cost of biopharmaceutical R&D: Is biotech different?
(Managerial and Decision Economics, 2007-06-01)
The costs of developing the types of new drugs that have been pursued by traditional pharmaceutical firms have been estimated in a number of studies. However, similar analyses have not been published on the costs of developing ...
Should the patent system for new medicines be abolished?
(Clin Pharmacol Ther, 2007-11)
Structural Effects of Regulation on Innovation in the Ethical Drug Industry
(Essays on industrial organization, in honor of Joe S. Bain, 1976)
Biosimilar competition: lessons from Europe
(Nature Reviews Drug Discovery, 2014-01-21)
An Economic Analysis of Global Policy Proposals to Prohibit Compensation of Blood Plasma Donors
(International Journal of the Economics of Business, 2016-05-03)
© 2016 International Journal of the Economics of Business.Human blood plasma and its derivative therapies have been used therapeutically for more than 50 years, after first being widely used to treat injuries during World ...
Longer Patents for Lower Imitation Barriers: The 1984 Drug Act
In this paper we analyze its likely impacts on competition in the pharmaceutical industry, the incentives for innovation, and general consumer welfare.
Implementation of the Biosimilar Pathway: Economic and Policy Issues
(Seton Hall Law Review, 2011)