comments last updated: July 25, 2024
In the WeedsDocument ID FDA-2024-N-3228-0001
Federal Register ID 2024-16405
Docket ID FDA-2024-N-3228
Want to get even more in the weeds?
Explore supplementary materials on regulations.govThe Food and Drug Administration FDA or Agency is announcing the establishment of a docket to obtain information and comments that will assist the Agency in assessing how best to advance the development of new biosimilar biological products biosimilars or biosimilar products as part of the Biosimilar User Fee Amendments of 2022 BsUFA III. As FDA continues to advance the development of biosimilars we are seeking input from industry on whether biosimilar product development would be best served by focusing on product class-specific guidance documents that address common development issues that apply to a broad class of products or by developing product-specific guidance documents similar to the approach taken in the Generic Drug User Fee Amendments GDUFA program.