Regulatory

Jan 01, 2007
Pharmaceutical Executive
By Pharmaceutical Executive Editors
There are lots of politicians, Senators Grassley and Waxman to name just two, who often say FDA is in the pharmaceutical industry's pocket. But anybody that has ever worked with FDA realizes not only is that not right, it's comically wrong.
Jan 01, 2007
Pharmaceutical Executive
A free flow of cheap counterfeits eclipses the ability of local manufacturers to create new products.
Jan 01, 2007
Pharmaceutical Executive
By Pharmaceutical Executive Editors
In Germany, the eight million richest citizens contribute nothing to the system that pays for the remaining 70 million insured people.
Jan 01, 2007
Pharmaceutical Executive
A new GAO report sets out to explain why drug development is so expensive and what to do about it. What the report says is important, but what it leaves out is a sense of how the world of pharma actually works.
Dec 01, 2006
Pharmaceutical Executive
Peter Rost, former Pfizer executive turned whistleblower, isn't just at war with his old employer. He's crusading against all of pharma, an industry he likens to the mob.
Dec 01, 2006
Pharmaceutical Executive
Even when NICE has said that drugs should be available to anyone who needs them, patients still have to convince their Primary Care Trusts.
Dec 01, 2006
Pharmaceutical Executive
To one major legal scholar, drug safety regulation isn't just about meeting standards, it's about what you take away from one group of patients in order to benefit the rest.
Dec 01, 2006
Pharmaceutical Executive
Documents from R&D, clinical affairs, regulatory, and sales and marketing can be in the millions. Throw electronic information into the mix, and the number of documents required for litigation increases exponentially.
Dec 01, 2006
Pharmaceutical Executive
Who should make decisions about drug safety—FDA or patients and doctors? In this excerpt from his important new book Overdose, the renowned (and ever controversial) legal scholar Richard A. Epstein argues that the current system overvalues risk, ignores individual differences, and needlessly deprives patients of valuable treatments.
Nov 01, 2006
Pharmaceutical Executive
The US Department of Justice thinks that "Average Wholesale Price" should mean just what the words say—no more, no less. Why? It's never meant that before.
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