FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: BIOSIMILAR USER FEE ACT; STAKEHOLDER CONSULTATION MEETINGS ON BIOSIMILAR USER FEE ACT REAUTHORIZATION; REQUEST FOR NOTIFICATION OF STAKEHOLDER INTENTION TO PARTICIPATE

WASHINGTON, Dec. 12 -- Food and Drug Administration has issued a notice called: Biosimilar User Fee Act; Stakeholder Consultation Meetings on Biosimilar User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate.

The notice was published in the Federal Register on Dec. 12 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders-including patient and consumer advocacy groups-notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Biosimilar User Fee Act (BsUFA). The statutory authority for BsUFA expi...