Making Advances Against Sickle Cell Disease

By: Patricia Oneal, M.D., and Rosanna Setse, M.D., M.P.H., Ph.D. The medical definition of sickle cell disease – a group of inherited red blood cell disorders caused by abnormal hemoglobin, called hemoglobin S or sickle hemoglobin, in red blood cells … Continue reading →

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Reducing the Hurdles for Complex Generic Drug Development

By: Scott Gottlieb, M.D. Earlier this year, I announced our Drug Competition Action Plan to advance new policies aimed at bringing more competition to the drug market. My goal was to improve access consumers have to the medicines that they … Continue reading →

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FDA is Advancing the Goals of the Orphan Drug Act

By: Scott Gottlieb, M.D. Three months ago, I committed to fully eliminate a backlog of about 200 orphan drug designation requests that were pending review with FDA, and to implement policies that would require FDA to respond to all new … Continue reading →

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