Biological Approvals by Year
The Center for Biologics Evaluation and Research (CBER) regulates products under a variety of regulatory authorities. The annual biological approvals are broken into lists based on these regulatory authorities. See the Development and Approval Process page for a description of what types of products are regulated at Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510(k)s.
Biological approvals older than 2 years are available on FDA Archive.
- 2022 Biological Approvals
- 2021 Biological Approvals
- 2020 Biological Approvals
- 2019 Biological Approvals
- 2018 Biological Approvals
- 2017 Biological Approvals
- 2016 Biological Approvals - ARCHIVED
- 2015 Biological Approvals - ARCHIVED
- 2014 Biological Approvals - ARCHIVED