Among the various schools and paradigms of thought, it is difficult to assess where we are, without first exploring the history and purpose of food and drug law. The Federal Food, Drug & Cosmetic (FDCA) Act was the first comprehensive federal law regulating food and drugs. It...

According to recent published reports, BioWorld Today’s research found more than 80 biotech companies cut about 5,000 jobs last year. So far this year, BioWorld has reported layoffs at 40 biotechs. A report from Burrill & Co. placed the numbers higher, estimating that 100 biotechs...

The many facets of policy interactions.... In Foundations of the Law, Professor’s Bailey Kuklin and Jeffrey Stempel assert that “during its history, United States law has frequently resulted from commercial, geographic, social and political conflict” (1994:138). The regulation...

The balance of risks vs. benefits Legislation and regulation has been celebrated and decried by many. One thing is certain, few ask the fundamental questions. Legislation and regulations all have publicly stated goals but the fundament al questions that must be considered are: Are...

I was recently asked what basic Legal & Regulatory Competencies that Regulatory Affairs Professionals must master. Thanks to notes from my Food, Drug & Medical Device Law class, the following offers a glimpse. • Understanding of governmental structure & Constitutional...

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