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Tropical Disease Priority Review Vouchers October 2016

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance provides information on the implementation of section 1102 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which added section 524 to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360n).2 Section 524 authorizes the FDA to award priority review vouchers to sponsors of certain tropical disease product applications that meet the criteria specified in that section. Since the enactment of FDAAA, we have received numerous inquiries about the scope of section 524 and how various aspects of section 524 should be interpreted. The purpose of this guidance is to provide a response to those questions.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0530.

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