Public Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA)
November 19, 2020
- November 19, 2020
The Food and Drug Administration (FDA or Agency) held a public meeting on 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 products. 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. FDA begins the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting to hear stakeholder views as we consider the next BsUFA. For more background information or to submit comments, please see the Federal Register notice with assigned docket FDA-2015-N-3326.
This meeting was held in virtual format only, at https://collaboration.fda.gov/bsufanov2020/. Registration was available at this link on Eventbrite.
The meeting recording can be accessed at https://collaboration.fda.gov/ptnqmlycvlft/.
EVENT POINT OF CONTACT
Emily Ewing, Emily.Ewing@fda.hhs.gov, Center for Drug Evaluation and Research, Food and Drug Administration
|Public Meeting on Biosimilar User Fee Act (BsUFA) Reauthorization||pdf (114.84 KB)|
|Opening Presentation BsUFA Background and Reauthorization Process||pdf (235.41 KB)|
|Panel 1 Healthy Women||pdf (12.23 MB)|
|Panel 1 JDRF International||pdf (533.83 KB)|
|Panel 2 American College of Rheumatology||pdf (861.46 KB)|
|Panel 2 Boston Medical Center Health System||pdf (387.38 KB)|
|Panel 2 Oncology Nursing Society||pdf (486.38 KB)|
|Panel 3 Biotechnology Innovation Organization||pdf (218.01 KB)|
|Panel 3 Pharmaceutical Research and Manufacturers of America||pdf (323.12 KB)|
|Transcript BsUFA Public Meeting 11-19-20||pdf (138.44 KB)|