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What is Biologic License Application
21 Feb 2024

What is Biologic License Application (BLA)?

A Biologic License Application (BLA) is a submission to the USFDA requesting permission to market and distribute a biologic product. Biologic products are therapeutic agents derived from living organisms, such as vaccines, blood and blood components, gene therapies, and certain protein-based therapies.

Submitting a BLA is a crucial step in the regulatory process for bringing a biologic product to market in the United States. The BLA includes comprehensive data on the safety, purity, and potency of the biologic product, as well as information on the manufacturing processes and controls. The goal of the BLA review process is to ensure that the biologic product is safe and effective for its intended use.

The FDA evaluates the data provided in the BLA to make a determination about the product’s approval. If the agency finds that the biologic product meets the necessary standards for safety and efficacy, it grants approval for marketing, and the product can be legally sold and distributed in the United States.

It’s important to note that the BLA process is specific to the United States, and other regulatory agencies in different countries may have their own processes for approving biologic products.

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