Regulatory

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.
Aug 01, 2005
Pharmaceutical Executive
SPCs extend a drug's basic patent protection for up to five years, to take into account the time that may have lapsed between the filing of a patent application and the granting of market authorization.
Aug 01, 2005
Pharmaceutical Executive
Integra v. Merck KGaA supports research by large pharmaceutical companies, but it also opens the door to greater use of compounded materials by all parties. Congress may have to clarify its scope.
Jul 01, 2005
Pharmaceutical Executive
By Pharmaceutical Executive Editors
Traders say parallel distribution of drugs generates savings for patients. Industry says it creates more profits for traders, leaving pharma with less R&D funding.
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