"Medicine is for the People, not for the Profits."
During my senior year, I was lucky to have a few job offers to evaluate. The top two were from Johnson & Johnson and Exxon. […]
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Business
Johnson & Johnson to Acquire Pfizer Consumer Healthcare
By Daniel R. Matlis Johnson & Johnson already had the title of the world’s most comprehensive and broadly based manufacturer of health care products, but
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What’s your FDA Site Selection Score?
By Daniel R. Matlis According to the Food, Drug, and Cosmetic Act, FDA statutorily required to inspect domestic drug manufacturing establishments at least once every
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Efficiency, Effectiveness and FDA All In The Same Sentence?
By Daniel R. Matlis In the past few years, CDER has made significant changes to advance and facilitate the review of electronic regulatory submissions. These
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FDA Must Become An Information Provider As Well As A Regulator
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
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AMA Calls For Moratorium On Advertising Of Prescription Drugs And Devices
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
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Are Post-it Notes Security's Worst Enemy?
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
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BearingPoint Joins SAFE’s Vendor Partner Program
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”)
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FDA Task Force Report Recommends e-Pedigree in Distribution and Addresses RFID Issues
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
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Convergence in Healthcare
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
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FDA Issues Guidelines for Using Statistics in Device Trials Speak Now or Forever Hold your Peace
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?”
Want to Buy a Bridge? The Promise of Service-Oriented Architecture
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
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