federal_register: 2019-09005

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2019-09005 Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher Notice The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of vouchers as well as the approval of products redeeming a voucher. FDA has determined that ULTOMIRIS (ravulizumab-cwvz) approved December 21, 2018, meets the redemption criteria. 2019-05-03 2019 5 https://www.federalregister.gov/documents/2019/05/03/2019-09005/notice-of-approval-of-product-under-voucher-rare-pediatric-disease-priority-review-voucher https://www.govinfo.gov/content/pkg/FR-2019-05-03/pdf/2019-09005.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation...  

Links from other tables