U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Laws Enforced by FDA
  4. Selected Amendments to the FD&C Act
  5. Food and Drug Administration Safety and Innovation Act (FDASIA)
  6. CBER Breakthrough Therapy Designation Requests
  1. Food and Drug Administration Safety and Innovation Act (FDASIA)
Back to Top