The Center for Biologics Evaluation and Research (CBER) regulates products under a variety of regulatory authorities. See the Development & Approval Process page for a description of what products are approved as Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510Ks.
Biologics License Applications and Supplements
New BLAs (except those for blood banking), and BLA supplements that are expected to significantly enhance the public health (e.g., for new/expanded indications, new routes of administration, new dosage formulations and improved safety).
- 2012 Biological License Application Approvals
- 2012 Biological License Application Supplement Noteworthy Approvals
- 2012 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
Other Applications Approved or Cleared by the Center for Biologics Evaluation and Research (CBER)
Medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products.
- Development & Approval Process (CBER)
- Biologics Products & Establishments
- Transfer of Therapeutic Products to the Center for Drug Evaluation and Research