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nidan7500

06/24/17 8:34 AM

#109535 RE: Penny Double #109518

Penny..thx,

Could this explain some of our VERY quiet time????




"At a Senate hearing on President Donald Trump's FY2018 budget request for the US Food and Drug Administration (FDA), Commissioner Scott Gottlieb vowed to eliminate the backlog of orphan drug designation requests and said he will soon release "modern and risk-based" tools for assessing new treatments, especially for rare diseases and conditions with no effective treatments.

"Right now we have a backlog of about 200 orphan drug designation requests where we haven't responded to sponsors," Gottlieb said, noting that the agency plans to "completely eliminate" this backlog within 90 days and will strive to address all future orphan designation requests within 90 days."