Regulatory

Jul 03, 2007
Pharmaceutical Executive
By Pharmaceutical Executive Editors
Although pricey, serialization with RFID is expected to reduce logistical errors and address some aspects of supply chain security
Jun 01, 2007
Pharmaceutical Executive
There's tremendous opportunity for us to understand how drugs can be used even better to get the right outcome, not only how to contain them in order to avoid complications or adverse events
May 01, 2007
Pharmaceutical Executive
Innovation in science is no quick trick, and neither is collaboration. Back in March 2004, FDA sounded a now-famous alarm: Despite the drug industry's 250 percent jump in spending on R&D, drug-development productivity had plunged by 50 percent over the previous decade. The report, which became known as the Critical Path Initiative (CPI), last year yielded an industry-wide call to arms regarding 76 action items (aka, the "Opportunities List") in six key areas: biomarker development, the streamlining of trials, the harnessing of informatics, improving drug manufacturing, public health initiatives against infections and bioterrorism, and special programs for adolescents, children, and other at-risk populations.
May 01, 2007
Pharmaceutical Executive
By Pharmaceutical Executive Editors
As the industry focuses its attention on the upcoming renewal of the Prescription Drug User Fee Act (PDUFA), there is a tendency to overlook two other significant pharmaceutical programs coming up for renewal and a related piece of legislation that has been introduced:
Apr 01, 2007
Pharmaceutical Executive
The Sarbanes-Oxley Act—or SOX, as it is dubbed (not always so affectionately)—requires companies to provide greater control and quality assurance across a vast spectrum of business processes. In practice, SOX plays out differently industry by industry and even company by company. But for pharma, one of the most pressing consequences is the need to improve the accuracy of revenue recognition.
Feb 01, 2007
Pharmaceutical Executive
Democrats want more transparency from pharma, and Republicans also are making noise about pricing. But government drug reimbursement is hard to get right and often creates perverse patient care incentives.
Feb 01, 2007
Pharmaceutical Executive
By Pharmaceutical Executive Editors
The UK's 'unsystematic' healthcare structure is getting a makeover. It includes a new single body to oversee drug development, and potential incentives for pharma—if it plays nice.
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.
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