By Daniel R. Matlis “This is a Challenging time for the FDA and the Industry” said Janet Woodcock, MD, FDA’s Deputy Commissioner of Operations and […]
FDA Must Become An Information Provider As Well As A Regulator Read More »
By Daniel R. Matlis The American Medical Association’s new policy on Direct to Consumer Advertising includes imposing a temporary moratorium on newly approved drugs and
AMA Calls For Moratorium On Advertising Of Prescription Drugs And Devices Read More »
By Daniel R. Matlis In his recent InformationWeek article entitled “Let The UBS Trial Be A Warning To You” Mitch Wagner covers the trial against
Are Post-it Notes Security's Worst Enemy? Read More »
By Daniel R. Matlis BearingPoint announced today that it will provide services to help pharmaceutical and healthcare organizations implement SAFE (“Signatures and Authentication For Everyone”)
BearingPoint Joins SAFE’s Vendor Partner Program Read More »
by Daniel R. Matlis In a long awaited move, the FDA announced on Friday June 9th, that it will fully implement regulations related to the
FDA Task Force Report Recommends e-Pedigree in Distribution and Addresses RFID Issues Read More »
By Daniel R. Matlis The Life-Sciences industry is undergoing a metamorphosis. Historically separate disciplines, like pharmaceuticals, devices, diagnostics, biotech, and even nanotech, are converging. This
Convergence in Healthcare Read More »
By Daniel R. Matlis Do you know that tense moment during the wedding ceremony, when the officiant says “speak now or forever hold your peace?”
By Daniel R. Matlis This is an excerpt of my recently published article in Medical Product Outsourcing. Medical device companies have been implementing manufacturing information
Want to Buy a Bridge? The Promise of Service-Oriented Architecture Read More »
By Daniel R. Matlis Do an internet search on Process Analytical Technology and you will be bombarded with sites for companies selling sensors, software and
Don’t forget the Process in PAT Read More »
By Daniel R. Matlis If I had a penny for every time I’ve been asked this question… A company is looking for a customer complaints/ CAPA
Should I Build or Should I Buy? Read More »
By Daniel R. Matlis My friends at MRO sent me an interesting whitepaper to review entitled “Understanding the Real Risk for Asset Intensive Industries”. In
One Size Does Not Fit All Read More »
