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The recent agreement between generic firms Teva Pharmaceutical and Alpharma to co-market a version of Pifzer’s epilepsy drug Neurontin (gabapentin) during Alpharma’s 180-day marketing exclusivity period violates federal drug laws governing generic exclusivity, Pfizer said in a citizen petition that argues exclusivity is not a right that can be transfered.
The nation's second-largest manufacturer of private-label OTC products was recently issued an FDA warning letter documenting more than a dozen deviations from current good manufacturing practice (cGMP) regulations.
Many of today's scientific breakthroughs have not been transferred into safe and effective medical treatments, despite record investments in research and development, according to top U.S. health officials at the 10th annual FDA Science Forum.
The FDA should determine which type of direct-to-consumer (DTC) advertising Americans would be more likely to read by testing different models of the brief summaries drugmakers are required to include in their ads, according to the FTC.
The Centers for Medicare & Medicaid Services (CMS) has selected Trailblazer Health Enterprises and Caremark/Advance PCS to provide implementation support for the Medicare replacement drug demonstration project.
Sen. Maria Cantwell (D-Wash.) is expected to introduce legislation next month that would compel pharmacy benefit managers (PBMs) to report details about their financial arrangements with drugmakers.
Unlike drugs developed in the 20th century and earlier that were designed to treat diseases after symptoms appeared and normal function had been lost, drugs created in the 21st century will be used to intervene before symptoms are evident and preserve normal function for extended periods, a top U.S. science official has predicted.
More drug firms can expect to go belly up unless they adopt a new approach to developing products that includes using statistical measures to identify successful drug candidates early and contributing clinical information to build drug and disease models that can be shared industrywide, an expert says.
A manufacturer of Rx cough/cold combination products has been cited by the FDA for multiple current good manufacturing practice (cGMP) violations at its Somerset, N.J., facility.
Acting FDA Commissioner Lester Crawford has ordered a comprehensive review of current outside activity requests from all agency employees in the wake of conflict-of-interest charges involving senior officials at two HHS agencies, including the FDA itself.