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 2016 are available on FDA Archive.

• 2024 Biological Approvals
• 2023 Biological Approvals
• 2022 Biological Approvals
• 2021 Biological Approvals
• 2020 Biological Approvals
• 2019 Biological Approvals (Archived)
• 2018 Biological Approvals (Archived)
• 2017 Biological Approvals (Archived)
• 2016 Biological Approvals (Archived)

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Related Information

• Biologics Products & Establishments
• Development & Approval Process (CBER)
• Federal Food, Drug, and Cosmetic Act (FD&C Act)
• Other Laws Affecting FDA
• FDA Acronyms & Abbreviations