Regulatory

Jun 01, 2005
Pharmaceutical Executive
When Jim Dougherty joined Mcgraw-Hill almost 30 years ago, medical journal publishing was just plain different than it is today. The days of the "three-martini lunch" were slowly coming to an end. Yet many companies still determined their ad schedules based on relationships. There was also less competition: without DTC or the Internet, journals garnered larger percentages of pharma's marketing mix. Today, Dougherty is group vice president of McGraw-Hill Healthcare Information and president of the Association of Medical Publications (AMP), an organization of publishing firms in the medical field. Like many of his peers, Dougherty has witnessed—and continues to witness—the transformation of the field. The future is bright, he says, but most certainly uncertain.
Jun 01, 2005
Pharmaceutical Executive
CMS envisions studies to show which drugs keep patients out of hospitals or how certain treatments can reduce side effects. Such analysis would support decisions on best practices in using medications.
Jun 01, 2005
Pharmaceutical Executive
By Pharmaceutical Executive Editors
A prolonged QT interval creates an electro-physiological environment that is favorable for the development of cardiac arrhythmias.
Jun 01, 2005
Pharmaceutical Executive
By Pharmaceutical Executive Editors
All too often, abuse liability and dependence potential are afterthoughts in the drug development process.
Jun 01, 2005
Pharmaceutical Executive
State clinical trials requirements are in place to protect people from being exploited, or unsafely exposed to compounds. Forty years later, it's easy to say, "How did this happen?"
May 01, 2005
Pharmaceutical Executive
OIG now requires corporate marketing departments and field sales reps to not only document how they promote products, but to also—for the first time—demonstrate the "intent" of marketing activities.
May 01, 2005
Pharmaceutical Executive
Just a decade ago, FDA was accused of dragging its feet on new drug applications. Now, supposedly, the agency is moving so fast that it's letting unsafe, insufficiently tested products into the marketplace.
May 01, 2005
Pharmaceutical Executive
A recently released report claims pharma hides bad clinical trial results and over-promotes drugs. Tougher regs are being called for.
May 01, 2005
Pharmaceutical Executive
The future of US healthcare is being created today in Medicare's demonstration programs. But how you respond to them depends a lot on what kind of company you are.
Apr 01, 2005
Pharmaceutical Executive
Reformers want to give FDA more clout, but agency officials say internal changes will help fix drug safety problems.
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