USFDA is advancing the Goals of the Orphan Drug Act

An Update from the USFDA Commissioner on the achievements to date

Three months ago, the agency 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 designation requests within 90 days of receiving them. Moreover, the agency pledged to never allow a backlog of these designations to accumulate again. Please read the full blog by Scott Gottlieb, MD, Commissioner USFDA:

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