Biosimilar User Fee Act Public Meeting October 20, 2016

Public | In Person

• Date: October 20, 2016

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The Food and Drug Administration 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 biological 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 biological 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 (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 the public views and comments and revise the recommendations as necessary.

Date:

October 20, 2016

Time:

9:00 AM – 2:00 PM

Location:

10903 New Hampshire Ave
Bldg 31 Rm 1503 (Great Room sections B/C)
Silver Spring, MD 20993

Webcast Recordings:

Part 1: https://collaboration.fda.gov/p8t969jkjvi/
Part 2: https://collaboration.fda.gov/p39c08pncmu/
Part 3: https://collaboration.fda.gov/p3msx7cvi15/

Contact:

For more information contact Amanda Roache: Amanda.Roache@fda.hhs.gov

 

Additional Information

• BsUFA II Public Meeting Agenda, October 20, 2016
• Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022
• Federal Register Notice
• BsUFA Meetings
• Presentation: Biosimilar User Fee Act (BsUFA II)Reauthorization Public Meeting