Free

Public Meeting on the Recommendations for BsUFA Reauthorization

Actions and Detail Panel

Free

Event Information

Share this event

Date and time

Location

Location

Online event

Event description
The FDA is holding a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA).

About this event

About this event

Date: November 2, 2021

Time: 9:00 a.m. to 12:00 p.m.

Webinar Link: https://fda.zoomgov.com/j/1610478285?pwd=MG1lN2hrYzBVTGhsd1F2eVhwZG1DQT09

Webinar Meeting ID: 161 047 8285

Webinar Password (Case-Sensitive): S9d&fx

Description

The Food and Drug Administration (FDA or Agency) is hosting a virtual public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological product applications. The current legislative authority for BsUFA expires in September 2022. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. Following discussions with the regulated industry, the Federal Food, Drug, and Cosmetic Act (the 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 such public views and comments and revise such recommendations as necessary.

[DEADLINE EXTENDED!] If you are interested in making a verbal comment during the Open Public Comment session of the meeting, please submit a request form prior to 11:59 pm (ET) on Tuesday, October 26th: https://www.surveymonkey.com/r/MZGJS9J. You will be contacted the week before the public meeting with additional information regarding your request.

As they become available, additional information (e.g. the Federal Register notice, the meeting agenda) will be provided at this link: https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027

Share with friends

Date and time

Location

Online event

Organizer FDA

Organizer of Public Meeting on the Recommendations for BsUFA Reauthorization

Save This Event

Event Saved