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…and the Federal Food, Drug, and Cosmetic Act (FDCA), and was unconstitutional under the dormant commerce clause because of its effect of regulating commerce occurring wholly outside that state’s borders….
…by a facsimile to (540) 231-9293, or by snail mail, using the address below. Virginia Tech Center for Applied Health Sciences Attention: Angela Correa 123 Duckpond Drive, mailcode 0418 Blacksburg,…
…and deceptively advertising the benefits of its Phillips Probiotics Colon Health (“PPCH”) supplements. The complaint alleges violation of consumer legal remedies and unfair competition laws, breach of express warranty, and…
…months of receipt. In Fiscal Years 2014-2017, the 50% figures from 2013 would go up to 60%, 70%, 80%, and 90%, respectively, while the 10-month (original) and 6-month (resubmission) review…
…this year, the Creating Hope Act of 2011 was introduced in the U.S. Senate (S. 606). The bill, like its nearly identical 2010 version (S. 3697), would, among other things,…
…(“FY”) 2012. (In separate notices, FDA will announce the FY 2012 user fee rates for animal drugs, animal generic drugs, medical devices, and fees under the Food Safety Modernization Act…
…United States (specifically, the United States Trade Representative, Ron Kirk) and eight other partners (i.e., Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, and Vietnam). Currently, the TPP is composed…
…an update on biosimilars, in-depth discussions on life-cycle management developments including, analyses of recent critical cases affecting patent life cycle planning, and much more. FDA Law Blog is a conference…