federal_register: 2015-20833

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
2015-20833 Use of Rare Pediatric Disease Priority Review Voucher; Approval of a Drug Product Notice The Food and Drug Administration (FDA) is announcing the recent approval of a drug product under an application for which the sponsor redeemed a rare pediatric disease priority review voucher. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to redeem priority review vouchers submitted by sponsors of product applications that might otherwise not qualify for priority review. These vouchers entitle the holder of such a voucher to priority review of a single human drug application submitted under the FD&C Act or the Public Health Service Act. FDA has approved PRALUENT (alirocumab), manufactured by Sanofi-Aventis U.S. Inc., under a priority review. 2015-08-24 2015 8 https://www.federalregister.gov/documents/2015/08/24/2015-20833/use-of-rare-pediatric-disease-priority-review-voucher-approval-of-a-drug-product https://www.govinfo.gov/content/pkg/FR-2015-08-24/pdf/2015-20833.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the recent approval of a drug product under an application for which the sponsor redeemed a rare pediatric disease priority review voucher. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as...  

Links from other tables