Regulatory

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.
Nov 01, 2006
Pharmaceutical Executive
By Pharmaceutical Executive Editors
The Deficit Reduction Act was designed to save the government money on Medicaid. But it also has the potential to change the very way pharma companies conduct business—if they can just figure it out.
Nov 01, 2006
Pharmaceutical Executive
By Pharmaceutical Executive Editors
When one company purchases another's branded trademarks as keyword search terms, the goal is to lure consumers to the buyer's site.
Nov 01, 2006
Pharmaceutical Executive
Long turnaround on ad reviews adds new complications to the process of developing marketing plans.
Oct 01, 2006
Pharmaceutical Executive
By Pharmaceutical Executive Editors
In cases that reached a verdict between 2002 and 2006, the branded pharma industry won six of six cases by verdict in Delaware, but lost six of eight in New Jersey, all by summary judgement. Despite what judges say, it's no coincidence.
Oct 01, 2006
Pharmaceutical Executive
Scientists are worried about what they can and cannot say. Senior scientists feel that if they voice the disagreements that are important to scientific discussion, they might have to leave FDA.
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