Author Archives: Jill Wechsler

New CDER “Super Office” to Promote Drug Quality

After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research, has administration approval for organizational changes to bolster programs and policies to ensure drug quality. The Department of Health and Human Services and the White House have finally signed off on her plan to establish a new CDER […]
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FDA’s New Emerging Technology Team to Assist “Innovative Manufacturers”

FDA’s Center for Drug Evaluation and Research is establishing an Emerging Technology Team (ETT) to assist innovative manufacturers in navigating the regulatory process and “overcoming roadblocks”.
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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 The agency hopes to issue draft guidance by the end of the year that will outline a […]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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