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OFFICE OF NEW DRUGS MODULE

BLA Approvals

With first-time BLA approvals, the product and facility are approved, and the company is issued a license number. The approval letter states that FDA issues the license in accordance with all regulations governing manufacturing of the product. The license authorizes the sponsor to introduce products into interstate commerce that the company has demonstrated to be in compliance with facility and product standards. License approval is an important milestone moment in the life of a product.

After approval, there are a variety of regulatory requirements:

  • Annual reports
  • Postmarketing commitment status
  • Adverse events submissions
  • Distribution summary submissions
  • Biologic deviation reports
  • Advertising and promotional labeling submissions
  • Periodic current Good Manufacturing Practice (cGMP) inspections -- usually every other year but the frequency is a function of the risk assessment performed by CDER's Office of Compliance

The firm must report any manufacturing and label changes to FDA.

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