Real Estate & Property Law

New L&C Law Scholarship: Streamlining NEPA to Combat Global Climate Change
Irma S. Russell, Streamlining NEPA to Combat Global Climate Change: Heresy or Necessity?, 39 Environmental Law Review 1049 (2009) This Article discusses the impact of the National Environmental Policy Act (NEPA) on the development of non-carbon energy sources...

FDA Issues a draft Guidance for Dissemination of Information on Unapproved Uses of Medical Products
The U.S. Food and Drug Administration (FDA) last Friday issued a draft guidance on “Good Reprint Practices” for regarding the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices...

FDA Issues Draft Guidance on Regulating Genetically Engineered Animals
FDA has issued draft guidance on regulation of genetically engineered animals. There is a 60-day comment period that ends November 18, 2008. The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for...

FDAs Postmarketing Studies and Clinical Trials Draft Guidance Gets Supported By Public Citizen
In an October 13 letter to the FDA, the well respected consumer advocacy organization Public Citizen, gave a strong endorsement to the FDA Draft Guidance on Postmarketing Studies and Clinical Trials...

FDA Draft Guidance for Industry: "Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products"
[Federal Register: January 8, 2010 (Volume 75, Number 5)] [Notices][Page 1060-1062] - Draft Guidance for Industry on Planning for the...

New L&C Law Scholarship: Taking Congress’s Words Seriously
Joel A. Mintz, Taking Congress’s Words Seriously: Towards a Sound Construction of NEPA’s Long Overlooked Interpretation Mandate, 38 Environmental Law Review 1031 (2008) This Article analyzes subsection 102(1) of the National Environmental Policy Act (NEPA) which directs that “to the fullest extent possible, the policies, regulations, and public laws of the United States shall be interpreted [...

FDA Issues Update on Safety Review Orlistat
Orlistat FDA Issues Update on Safety Review

Aurora Loan Faces Class Action over Mortgage Review Services
Aurora Loan Faces Class Action over Mortgage Review Services

FDA Review of Prostate Cancer Treatment Prompts Warning of Risk for Diabetes
Prostate Cancer Treatment FDA Review Prompts Warning of Risk for Diabetes

Xigris
Study Prompts FDA Safety Review

Lipitor
Review of Studies Show No Significant Benefit in Women

Wrinkle-Fillers
FDA to Review Labeling due to Adverse Event Reports