Tag Archives: FDA

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 The agency hopes to issue draft guidance by the end of the year that will outline a […]
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Ebola Crisis Could Spur Broader R&D Efforts

Up until a few months ago, there was little industry interest or public support for developing vaccines and treatments to combat the Ebola virus. Now the rush is on to launch clinical trials of therapies with some potential effectiveness against the disease. The situation has also encouraged FDA and regulatory authorities to facilitate these efforts […]
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Implementing the Generic Drug User Fee Act: Struggles and Successes

Two years into the Generic Drug User Fee Act (GDUFA) program, enacted in July 2012, FDA officials are striving to meet goals and timelines for speeding new generic drugs to market. Agency reviewers have made some progress in eliminating the huge backlog in abbreviated new drug applications (ANDAs) pending in the Office of Generic Drugs […]
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