Regulatory

Oct 01, 2005
Pharmaceutical Executive
The pharmaceutical industry devotes more of its promotional budget to samples than anything else, unless you count the army of sales representatives that delivers them. This year, the average wholesale price of samples passed out to doctors will approach $15 billion—roughly twice the value of samples five years ago. And although few in the industry have come to grips with it, the federal regulations governing this enormous investment have undergone drastic changes.
Oct 01, 2005
Pharmaceutical Executive
The client-agency relationship is a product of its environment. Chock-full of regulatory requirements, scandals, and heightened FDA scrutiny, the current environment leaves much to be desired. But this is hardly news for the pharma industry.
Oct 01, 2005
Pharmaceutical Executive
By Pharmaceutical Executive Editors
UK courts are affirming the belief that medical research and drug development have made a huge contribution to people's quality of life, and that a small but vital part of that work involves the use of animals.
Oct 01, 2005
Pharmaceutical Executive
Product managers would be less disrupted if compliance activities at pharma companies were more anticipatory than reactionary.
Oct 01, 2005
Pharmaceutical Executive
Think of the role compliance plays in your job. Now imagine that level of concern increased by 25 percent, 50, or even more. That's what pharma has to look forward to in the next few years, as the effects of old regulatory initiatives, such as 21 CFR Part 11 and Sarbanes Oxley, start fully kicking in—and as we experience the as-yet-unknown regulatory fallout of the new concern with drug safety. It's no surprise that a great portion of this volume of Pharm Exec's Successful Product Manager's Handbook series is given over to compliance.
Oct 01, 2005
Pharmaceutical Executive
By Pharmaceutical Executive Editors
Increased availability of clinical-trials information allows patients to identify trials in which they may participate, assess safety issues, and easily register.
Oct 01, 2005
Pharmaceutical Executive
Many still regard FDA's approach as costly and unnecessary. But the prospect of qualifying for purchase by PEPFAR is attracting applicants. The policy has helped bring news AIDS treatments to market.
Oct 01, 2005
Pharmaceutical Executive
By Pharmaceutical Executive Editors
In an opinion piece in the September 8 New England Journal of Medicine, Harvard medical professor and long-time industry critic Jerry Avorn takes a whack at FDA, accusing the agency of practicing a level of science that wouldn’t pass muster anywhere else in research—science that’s only "good enough for government work.";
Sep 01, 2005
Pharmaceutical Executive
By Pharmaceutical Executive Editors
My doctor and I have two different visions of an avian influenza pandemic. She's picturing regular flu season, but worse. I'm imagining 1918. Does the conflict sound familiar?
Sep 01, 2005
Pharmaceutical Executive
Class actions threaten industries that deal with the public. If European lawmakers remove the restriction on class-action suits, consumers will be free to file cases. Pharma companies should take heed.
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