The Food and Drug Administration will eliminate its backlog of orphan drug designation requests within the next two months, according to FDA Commissioner Scott Gottlieb, MD.
"Right now we have a backlog of about 200 orphan drug designation requests where we haven't responded to sponsors," Dr. Gottlieb said Tuesday during a Senate hearing, reports Regulatory Focus.
The FDA hopes to "completely eliminate" this backlog within 90 days and plans to respond to all further submitted requests within a 90-day period, according to the report.
Dr. Gottlieb said the agency will create an improved request template and update several drug development guidance documents to streamline the orphan drug review process. The FDA will also release a new guidance detailing the agency's process for evaluating rare disease drugs.
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