Search Results for citation:"90 FR 16692"

The Food and Drug Administration (FDA) has announced the approval of a product called TREMFYA (guselkumab) using a priority review voucher. This type of voucher is given by the FDA under the Federal Food, Drug, and Cosmetic Act to sponsors with approved treatments for rare pediatric diseases. The approval of TREMFYA, which was finalized on March 20, 2025, met all necessary criteria for using the voucher. Information on both the priority review voucher program and TREMFYA is available on the FDA's website.

The Food and Drug Administration (FDA) has issued a correction notice regarding a previously published document in the Federal Register on January 7, 2025. The original document announced the availability of final guidance for industry titled "Action Levels for Lead in Processed Food Intended for Babies and Young Children" but contained an error in the Background section. The correction clarifies that the parenthetical citation should refer to "88 FR 4797" instead of the incorrect information. This correction ensures accuracy in the FDA's guidance documentation.

The Food and Drug Administration (FDA) has announced changes to a previous notice about a joint meeting involving the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. These changes involve updates to the meeting's dates, addresses, and procedures. The meeting is now scheduled for May 5, 2025, from 8 a.m. to 5 p.m. Eastern Time, and public comments will be accepted until the day before. The purpose of the meeting remains to discuss issues regarding extended-release/long-acting opioid analgesic postmarketing requirements.