Regulatory

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.
Jul 01, 2005
Pharmaceutical Executive
Pilot projects involving RFID technology are appearing at some major pharma companies. But uptake of RFID-based solutions remains limited due to concerns about accuracy, reliability, and ROI.
Jul 01, 2005
Pharmaceutical Executive
For pharma companies large and small, one of the most pressing challenges of the next few years will be to understand compliance at a much deeper level, to obtain the tools to make it possible.
Jul 01, 2005
Pharmaceutical Executive
Procter & Gamble Pharmaceuticals discovered that a network resulting from even a modest integration offered benefits that exceeded the sum of its parts.
Jul 01, 2005
Pharmaceutical Executive
If congressmen gathered to work through the nuances of banning ED drugs from reimbursement under Medicare, they'd still back the ban. But the decision would be grounded in lack of faith in prescribing behavior, not disregard for a debilitating condition.
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