Now showing items 1-5 of 5
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 ...
Mergers and Alliances in Pharmaceutical: Effects on Innovation and R&D Productivity
(The Economics of Corporate Governance and Mergers, 2008-01-01)
This book provides an insightful view of major issues in the economics of corporate governance (CG) and mergers. It presents a systematic update on the developments in the two fields during the last decade, as well ...
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, ...
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 ...
Follow-on biologics: data exclusivity and the balance between innovation and competition
(Nature Reviews Drug Discovery, 2008-06)