federal_register: E8-24932

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
E8-24932 Draft Guidance for Industry on Tropical Disease Priority Review Vouchers; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Tropical Disease Priority Review Vouchers." There has been significant outside interest in FDA's interpretation of section 1102 of the Food and Drug Administration Amendments Act (FDAAA), which adds a new section 524 to the Federal Food, Drug, and Cosmetic Act (the act). Section 524 makes provisions for awarding priority review vouchers for future applications to sponsors of tropical disease product applications that meet the criteria specified by the act. This draft guidance explains to internal and external stakeholders how FDA intends to implement the provisions of section 524. 2008-10-20 2008 10 https://www.federalregister.gov/documents/2008/10/20/E8-24932/draft-guidance-for-industry-on-tropical-disease-priority-review-vouchers-availability https://www.govinfo.gov/content/pkg/FR-2008-10-20/pdf/E8-24932.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Tropical Disease Priority Review Vouchers." There has been significant outside interest in FDA's interpretation of section 1102 of the Food...  

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