Regulatory

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.
Sep 01, 2005
Pharmaceutical Executive
Implementation of policies that respond to industry compliance standards poses a considerable burden for companies in terms of time and expense. Unless industry changes its response to state laws, the condition will worsen.
Sep 01, 2005
Pharmaceutical Executive
By Pharmaceutical Executive Editors
If the legislation passes, companies will be rewarded with a six-month extension of market exclusivity if they conduct pediatric trials. And under the proposal, companies that fail to comply can be penalized.
Sep 01, 2005
Pharmaceutical Executive
FDA could lose 251 employees under the administration's proposed 2006 budget. The agency will try to do more with less through risk-management practices, but important tasks will fall by the wayside.
Aug 01, 2005
Pharmaceutical Executive
Manufacturers will have to incorporate Part D–specific messaging into all of their current marketing materials. In addition, they should consider publication plans and CME that specifically address the needs of seniors.
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