Search Results for citation:"86 FR 9514"

The Food and Drug Administration (FDA) has awarded a priority review voucher to Alnylam Pharmaceuticals Inc. for their product, OXLUMO (lumasiran) injection. This product is used to treat a rare disease called primary hyperoxaluria type 1, which helps lower urinary oxalate levels in both children and adults. The voucher is part of a program set by the Federal Food, Drug, and Cosmetic Act, which recognizes drugs designed for rare pediatric diseases. The FDA is required to announce when such vouchers are awarded.

The Food and Drug Administration (FDA) has submitted a proposed information collection to the Office of Management and Budget (OMB) for review, as required under the Paperwork Reduction Act of 1995. This proposal relates to tracking certain high-risk medical devices, which helps to quickly locate devices and notify patients or practitioners about recalls or risks. The collection applies to manufacturers, importers, and distributors of these medical devices, and aims to ensure effective tracking and information sharing in case of device defects. The FDA has estimated that the annual burden for respondents is around 615,380 hours, with approximately 22,000 entities subject to these tracking requirements.