http://regulatoryoverlord.com/blog All Things Regulatory & Legal for Drugs, Biologics, Medical Devices, Nanotechnology and Combination Products. Wed, 09 Dec 2009 21:16:55 +0000 http://backend.userland.com/rss092 en [caption id="attachment_310" align="aligncenter" width="447" caption="The Chasmic Shift in Disruptive Business Climates"][/caption] 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 ... http://regulatoryoverlord.com/blog/2009/12/10/the-chasmic-shift-in-disruptive-business-climates/ 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. It was a naive perspective, filled with partial anecdotes, ... http://regulatoryoverlord.com/blog/2009/06/04/talkback-response-to-article-in-nature-a-to-do-list-for-the-new-fda-commissioner-by-susan-okie-md/ [caption id="attachment_277" align="alignleft" width="547" caption="BIOMEDevice Forum 2009"][/caption] (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. BIOMEDevice Forum ... http://regulatoryoverlord.com/blog/2009/05/06/the-future-of-convergent-technologies-report-from-biomedevice-2009-executive-forum/ [caption id="attachment_258" align="alignleft" width="560" caption="A current pacemaker. Future devices are getting smaller and more complex."][/caption] 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 and others, life ... http://regulatoryoverlord.com/blog/2009/04/10/the-medical-device-industry-and-the-role-of-cdrh/ [caption id="attachment_244" align="alignnone" width="600" caption="The potential and benefits of nanotechnology are promising and unknowingly dangerous"][/caption] 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 and settings. The folowing are a few issues ... http://regulatoryoverlord.com/blog/2009/04/07/introduction-to-the-nanotechnology-series/ 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, Feminist Legal Theory: A Primer. Without going ... http://regulatoryoverlord.com/blog/2009/04/02/plan-b-feminism-as-practice-theory/ [caption id="attachment_153" align="alignnone" width="560" caption="What will it be? The Blue or Red pill?"][/caption] 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 ... http://regulatoryoverlord.com/blog/2009/04/02/the-imbedded-american-notion/ 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 was strictly an ... http://regulatoryoverlord.com/blog/2009/03/25/reflections/ 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 laid off more than 6,000 ... http://regulatoryoverlord.com/blog/2009/03/23/bioslash-continues%e2%80%a6/ [caption id="attachment_76" align="alignleft" width="416" caption="The many facets of policy interactions...."][/caption] 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 of medical products is no different; various perspectives apply ... http://regulatoryoverlord.com/blog/2009/03/23/the-policy-connection-3/