POLICY | REGULATORY OVERLORD CHRONICLES

The Chasmic Shift in Di...

The Chasmic Shift in Disruptive Business Climates It has been a few months since I have had an opportunity to write for pleasure. After completing my doctoral work on August 25th, working on a major global submission, and teaching 2 sections of Healthcare Marketing and Communications...

Talkback: Response to A...

ARTICLE: http://content.nejm.org/cgi/content/full/360/14/1373 The article in Nature by Dr. Susan Okie titled, A To-Do List for the New FDA Commissioner, was an unfair indictment of an agency that still maintains the world’s “gold standard” and has done so for over 100 years....

The Future of Convergen...

BIOMEDevice Forum 2009 (Report from BIOMEDevice 2009 Executive Forum) I took time off to finalize my doctoral thesis draft and research bleeding edge companies presenting at BIOMEDevice 2009 held at Boston Convention Center on Tuesday April 21st through Wednesday, April 22, 2009....

The medical device indu...

A current pacemaker. Future devices are getting smaller and more complex. The public trust manufacturers of medical products to develop and commercialize devices that are safe for humans. There are many types of medical devices varying in complexity, some as simple as contact lenses...

Introduction to the Nan...

The potential and benefits of nanotechnology are promising and unknowingly dangerous The series on nanotechnology will address many important and foundational questions posed in the entry and commercialization of novel particles employing novel technology and useful in multiple applications...

Plan B - Feminism as Pr...

Plan B - Barr Pharmaceuticals (subsidiary of Teva Pharmaceutical Industries) I thought I would step outside my comfort zone and take a look at the Plan B controversy in a feminist legal theory perspective using Levit, Nancy & Robert Verchick & Martha Minow’s 2006,...

The imbedded American n...

What will it be? The Blue or Red pill? There is an imbedded American notion that the government and the three branches are the protector, arbiter and architects of the public good. The public assumes that if the FDA allows a regulated product on the market it is synonymous with a...

Reflections on law and ...

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...

The Policy Connection...

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...

Legal & Regulatory...

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...