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FDA Approval for Biologic/Biological Products

*Procedure for FDA Approval of Biologics/Biological Product:

  1. R&D Development.
  2. Pre-clinical trials are conducted on a small scale.
  3. Clinical trials on humans are conducted, and they compile the results of their laboratory and other pre-clinical testing, as well as information about the manufacturing technology and the quality of the vaccine, and then submit these to FDA in the form of an Investigational New Drug (IND) application.
  4. Approval of FDA happens after consulting the Vaccines and Related Biological Products Advisory Committee (VRBPAC) (if needed) and considering the information provided in the Biologics License Application (BLA).

*List of Documents/Forms for Biologics/Biological Product Approval:

The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. For that, Form 356h has to be filed, and the following information has to be mentioned:

  • Applicant information
  • Product/manufacturing information
  • Pre-clinical studies
  • Validation criteria for important processes
  • Case Reports
  • Clinical studies
  • Labeling


  • One time waiver of fee for first BLA from a small business.
  • BLA supplements that require clinical data for approval are assessed half the full application fee; however, NDA (New Drug Application) or BLA supplements that do not require clinical data for approval are not assessed a fee.
  • Standard fee: $322,147 approx. (for small business - $80,537)

*Mode of Filing:


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