On the recordAugust 3, 2017
I am pleased the Senate advanced H.R. 2430, the FDA Reauthorization Act. This bipartisan, bicameral legislation ensures Americans will continue to have access to safe medications and the FDA has the tools they need to continue our Nation's approval process remains the gold standard. I am also pleased to see tropical disease priority review voucher state that a sponsor qualifies for a neglected tropical disease priority review voucher under existing law until September 30, 2017, so long as they submit at least one portion of a human drug application by that date. I would like to ask Senator Isakson if it is our intention to allow for sponsors who have been working in good faith with the Food and Drug Administration on a human drug application for a product that addresses a neglected tropical disease to qualify for a priority review voucher, as long as they begin a rolling submission to the agency by September 30, 2017?
Source
govinfo.gov




