On 10 August 2023, the FDA published draft guidance for industry ‘Classification Categories for Certain Supplements Under BsUFA III’ seeking comment and suggestions by 10 October 2023.
The guidance provides recommendations for applicants and FDA review staff on six classification categories for original and resubmitted supplements to approved applications. The commitment letter associated with the Biosimilar User Fee Amendments of 2022 sets out these supplement classification categories and their associated review performance goals. The guidance intends to help applicants identify the appropriate classification category and review goal date of the supplement being submitted.