Tag Archives: FDA

FDA "Stymies Competition in Drug Industry", Says PCMA

By Randi Hernandez. The Pharmaceutical Care Management Association (PCMA), an organization that represents the nation’s leading pharmacy benefit managers (PBMs), which administer prescription drug plans for over 210 million Americans, released a new white paper investigating FDA’s influence on drug prices and competition in the pharmaceutical marketplace. The PCMA argues that competition within branded drugs […]
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Amgen and Sandoz in Legal Battle Over Biosimilar Application

By Randi Hernandez In a landmark lawsuit over the first biosimilar application, Amgen is suing Sandoz for unlawfully refusing to follow the patent resolution protocol laid out by the rules of the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
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Legislators Urge Added Incentives for Ebola Drug Development

Leading Senators are proposing legislation to add Ebola to the list of diseases eligible for priority review vouchers from the Food and Drug Administration as an incentive for biopharma companies to invest in treatments for this deadly disease. The priority review voucher (PRV) program for neglected tropical diseases (NTDs) currently applies to 16 deadly conditions […]
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Global Gaps in Standards Threaten Biosimilar Development

Although biopharmaceutical companies and regulatory authorities have made considerable progress in establishing policies for bringing biosimilars to market, key differences and gaps in requirements for testing and documenting product similarity still characterize the European Union, the U.S. and other regions. The EU’s European Medicines Agency (EMA) has set the regulatory pace, with 18 products approved since 2006, […]
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FDA Readies Quality Metrics Measures

 After almost two years of discussion and analysis, the Food and Drug Administration is finalizing a proposal for collecting data from manufacturers to help measure the performance of manufacturing operations and the quality of resulting drugs and biologics. The agency hopes to issue draft guidance by the end of the year that will outline a […]
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