Regulatory

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.
Apr 01, 2005
Pharmaceutical Executive
Could it be that someone's finally going to wipe the grin off Smiling Bob's face? As we were putting this issue to bed, the Cincinnati newspapers reported that federal agents had raided the offices of Berkeley Premium Nutraceuticals, a company best known for its "natural male enhancement" pill, Enzyte, and for its repulsive television commercials starring Bob. The US Postal Service led the operation, which also included the FBI, IRS, and FDA. They froze bank accounts, sent employees home, and combed records, attempting to determine whether Berkeley, which has accumulated more than 5,000 complaints with the Cincinnati Better Business Bureau and the Ohio attorney general's office since 2001, had committed mail fraud.
Apr 01, 2005
Pharmaceutical Executive
Every quarter, pharmaceutical manufacturers confront a dizzying array of price reporting obligations. Participation in the Medicare, Medicaid, Veterans Administration (VA), and Public Health Service (PHS) programs requires manufacturers to collect, organize, distill and manipulate vast quantities of information, and to generate from that data reportable figures that can have an enormous impact on the company's bottom line. It is critical that these figures be correct, not only to help ensure the integrity of these public programs, but because submission of false data to a federal agency is a prosecutable criminal offense, and the civil penalties and exposure can be staggering.
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