A Biologics License Application (BLA) is submitted to the Food and Drug Administration (FDA) to obtain permission for distribution of a biologic product across the states. It is regulated under 21 CFR 600-680. A BLA can be submitted by an applicant who is responsible for the safety and efficacy of the product.

Submitting a BLA

To submit a BLA, applicants are required to submit a Form FDA 356h to the Centre for Biologics Evaluation and Research (CBER), which handles the regulations for biologics. A Form FDA 356h is an application submitted to place a new drug, biologics or antibiotics in the market. CBER accepts both paper as well as electronic submissions. The following information is required to be submitted with the Form 356h:

  • As part of the application, a summary of the necessary information is required
  • Information related to the applicant of the BLA
  • A section for preclinical data
  • A section for clinical data which includes data about the safety and efficacy of the product
  • Labeling draft of the product
  • Information related to the manufacturing, controls and chemistry of the product
  • A summary of data validating the processes involved in the manufacturing of the product
  • A detailed description of the manufacturing facility
  • Case reports on the clinical experience of the manufacturer
  • Description of serious events and case report forms
  • Index

Once the application is submitted to the FDA, the authority evaluates if the application is complete. The FDA also conducts an initial review of the standard operating procedures and the data submitted. If necessary, the FDA can request the manufacturer for additional information regarding any aspect.

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