Now showing items 1-10 of 33
Impact of economic, regulatory, and patent policies on innovation in cancer chemoprevention.
(Cancer Prev Res (Phila), 2008-07)
Chemoprevention agents are an emerging new scientific area that holds out the promise of delaying or avoiding a number of common cancers. These new agents face significant scientific, regulatory, and economic barriers, however, ...
Follow-on biologics: data exclusivity and the balance between innovation and competition
(Nature Reviews Drug Discovery, 2008-06)
Generic Competition in the U.S. Pharmaceutical Industry
(International Journal of the Economics of Business, 2006-02)
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 ...
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)
Are the Economics of Pharmaceutical R&D Changing? Productivity, Patents and Political Pressures
Pharmaceutical R&D competition in the 1980s and 1990s was characterized by rising R&D expenditures, favorable returns to innovators, and the introduction of many new classes of drugs with high social benefits. However in ...
How did the 2003 prescription drug re-importation bill pass the house?
(Economics and Politics, 2006-03-01)
We examine the major interest groups in the debate over allowing the re-importation of prescription drugs by utilizing a logit model and instrumental variables. Consistent with political support approach, the evidence suggests ...
Increasing R&D Incentives for Neglected Diseases: Lessons from the Orphan Drug Act
(International Public Goods And Transfer Of Technology Under A Globalized Intellectual Property Regime, 2005)