federal_register: 2014-27022
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-27022 | Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Rare Pediatric Disease Priority Review Vouchers." Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria specified in that section. These vouchers can be used when submitting future human drug marketing applications that would not otherwise qualify for priority review. These vouchers can be sold or transferred for use to another sponsor any number of times before the voucher is used, as long as the sponsor making the transfer has not yet submitted the application. Because there exists a need for products for rare pediatric diseases, this program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. | 2014-11-17 | 2014 | 11 | https://www.federalregister.gov/documents/2014/11/17/2014-27022/rare-pediatric-disease-priority-review-vouchers-draft-guidance-for-industry-availability | https://www.govinfo.gov/content/pkg/FR-2014-11-17/pdf/2014-27022.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Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Rare Pediatric Disease Priority Review Vouchers." Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA will award priority... |