FDA Opens Registration for Public Meeting on Reauthorizing the Biosimilar User Fee Act (BsUFA)
The Food and Drug Administration is announcing the November 19, 2020 public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027. BsUFA authorizes FDA to collect user fees to support the review of biosimilar biological products. The current legislative authority for BsUFA expires in September 2022.
The purpose of this virtual public meeting is to allow interested stakeholders an opportunity to provide their views on the program’s reauthorization as FDA considers which, if any, features to propose, update, or discontinue in the next BsUFA. The BsUFA III meeting agenda will include presentations by FDA staff and panels representing multiple stakeholder groups, as well as time allotted for public comment and discussion. Public comments will also be accepted through December 19, 2020, by submission to docket No. FDA-2015-N-3326, which will be published prior to the public meeting.
To attend this meeting, please register by November 5, 2020. Registrants will receive instructions to access the live webcast of the virtual meeting. The meeting’s agenda, webcast information, additional materials, and any other updates will be posted to FDA’s website as they become available.
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