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Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.
October 28, 2014
Leading US senators are proposing legislation to add Ebola to the list of diseases eligible for priority review vouchers from FDA as an incentive for biopharmaceutical companies to invest in treatments for this deadly disease.
October 16, 2014
After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), has administration approval for organizational changes to bolster programs and policies to ensure drug quality.
October 06, 2014
After almost two years of discussion and analysis, FDA 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.
October 02, 2014
Demand for new therapies and vaccines spotlights production challenges.
September 24, 2014
To encourage adoption of advanced manufacturing technologies that can help industry meet high quality standards consistently, and avoid drug recalls and shortages, 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 overcome roadblocks.
September 02, 2014
FDA demands accurate manufacturing and test information to ensure product quality.