Preparation of Biologics License Application (BLA) for USFDA: An Overview

A Biologics License Application (BLA) is submitted by a manufacturer of vaccines, blood and blood components, somatic cells, gene therapy and other biological drug products to get marketing permission from regulatory authority of the intended market.Application can be submitted by an applicant (manufacturer) and must contain the data derived from non-clinical laboratory studies and clinical studies which demonstrate that the manufactured product meets prescribed requirements of safety, purity and potency.Among further things like safety and purity assessments must consider the storage and testing of cell substrates that are often used to manufacture biologics.The Center for Biologics Evaluation and Research (CBER), the Center within FDA, regulates and evaluates the application as per the Federal Food, Drug and Cosmetic Act 1938.Distribution or sell of biologic products in US is regulated under 21 CFR 600-680.