Home » FDA Completes Guidance on Tropical Disease Priority Review Vouchers
FDA Completes Guidance on Tropical Disease Priority Review Vouchers
October 11, 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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