The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022. BsUFA authorizes FDA to collect fees and use them for the process for the review of biosimilar biologic product applications. The current legislative authority for BsUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting biosimilar biologic product user fees in future fiscal years. Following an initial consultation with public stakeholders and discussions with the regulated industry, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider the public views and comments and revise the recommendations as necessary.
The purpose of the meeting is to hear the public's views on the proposed recommendations for the reauthorization of BsUFA II. The recommended changes for the reauthorization of BsUFA and additional meeting information can be found on the FDA website: http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm461774.htm
The meeting will take place at FDA's White Oak campus and will also be broadcast on the web. Please select the appropriate ticket time when you register - "In Person Attendee" to attend at FDA's campus or "Webcast Attendee" to view the meeting from a remote location. The website to access the meeting will be emailed to those who have registered as a webcast participant approximately one week in advance. It is recommended that remote attendees check their spam folder if they do not receive the webcast link approximately one week in advance.