Search Results for citation:"90 FR 16693"

The Food and Drug Administration (FDA) has announced the approval of a product that uses a priority review voucher under the Rare Pediatric Disease Priority Review Voucher Program. This program, authorized by the Federal Food, Drug, and Cosmetic Act, allows the FDA to award vouchers to sponsors of approved drug applications for rare pediatric diseases. The supplemental application for AMVUTTRA (vutrisiran), approved on March 20, 2025, met the criteria for redeeming such a voucher, demonstrating its commitment to addressing rare diseases in children.

The Health Resources and Services Administration (HRSA), part of the Department of Health and Human Services (HHS), announced a list of petitions received under the National Vaccine Injury Compensation Program. This program aims to provide no-fault compensation to individuals injured by childhood vaccines by allowing them to file a petition with the U.S. Court of Federal Claims. The HRSA has published details of petitions received in March 2025, which include the petitioner's name, location, and case number. Those interested can submit relevant information regarding the cases to the court.