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Creating A Roadmap For Achieving Intergenerational Environmental Justice, Clifford Rechtschaffen
Creating A Roadmap For Achieving Intergenerational Environmental Justice, Clifford Rechtschaffen
The Climate of Environmental Justice: Taking Stock (March 16-17)
Presenter: Clifford Rechtschaffen, Professor of Law and Director, JD Environmental Law Program; Co-Director, Environmental Law and Justice Clinic, Golden Gate University School of Law
5 pages.
Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher
Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher
Michigan Telecommunications & Technology Law Review
Biologics are becoming increasingly important for the potential treatment of widespread diseases such as cancer, anemia, and diabetes. As hundreds of biologics are going off-patent, the market has become ripe for the introduction of generic biologics. A regulatory pathway for biogenerics, however, is virtually nonexistent. The purpose of this paper is thus to analyze how a successful legislative pathway for generic biologics might be designed. The current regulatory scheme, economic concerns, health and safety concerns, and the need to provide proper incentives for innovation are analyzed. Finally, recent Congressional bills are outlined and critiqued, through which the structure of a …
Documents, Leaks, And The Boundaries Of Expression: Government Whistleblowing In An Over Classified Age, Susan Nevelow Mart
Documents, Leaks, And The Boundaries Of Expression: Government Whistleblowing In An Over Classified Age, Susan Nevelow Mart
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