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...

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....

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....

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...

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...

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...

This blog contains personal views of various topics that arise in regulatory, legal and policy arena for drugs, biologics, medical devices, combination products and nanotechnology. Please read our DISCLAIMER about the nature of this blog, and understand that you are accepting its...