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Pharmaceuticals / Regulatory Affairs

FDA Completes Guidance on Tropical Disease Priority Review Vouchers

Oct. 12, 2016

The FDA published final guidance on its priority review voucher program for tropical diseases, saying that a voucher does not offer a complete guarantee of an approval within six months.

The agency also loosened its restrictions on the eligibility of drug-drug combinations, in a change from the 2008 draft version of the guidance.

The guidance reiterated the FDA’s commitment to responding to 90 percent of priority-designated applications within six months, but stated that its answer could also come in the form of a complete response letter, with a description of specific deficiencies, instead of an approval.

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