 that answers questions regarding priority review vouchers for certain rare pediatric disease treatments that meet criteria of the Food, Drug, & Cosmetic Act (FD&C Act). As part of the FD&C Act, FDA may give special incentives to companies for the development of treatments for rare pediatric diseases. This draft guidance revises a previous draft guidance and clarifies the qualifications and process for requesting priority review vouchers.

	Specifically, the guidance gives detailed answers to questions regarding the definition of a rare pediatric disease, eligibility requirements, a sponsor’s responsibilities after approval of an application, designation information requests, the submission process, marketing applications, and use and transfer of a rare pediatric disease priority review voucher. The guidance also discusses drug-drug combinations, previously approved drugs, and orphan drug designation questions.

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The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.