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Biologic License Application clinical data

The data generated in Phase 1, 2, and 3 clinical trials provide the basis for a sponsor s application for a product license to market the drug or biologic. The application for a new pharmaceutical is known as a New Drug Application (NDA) that for a biologic is a Biologic License Application (BLA)A multidisciplinary internal FDA team of scientists reviews the application, which must provide sufficient... [Pg.36]

The results of the preclinical and clinical trials and all manufacturing, chemistry, quality control, and test methods data are submitted to FDA in the form of a new drug application (NDA) or a biologies license application (BLA) for marketing approval. [Pg.567]

For all other biological products, sponsors must submit two applications, an establishment license application (ELA) and a product license application (PLA). Both submission processes (BLA or ELA/PLA) may require nonclinical and clinical data, chemical and biological information, and information on the product manufacturing process and facility. Ultimately, the single-application... [Pg.183]

See other pages where Biologic License Application clinical data is mentioned: [Pg.12]    [Pg.32]    [Pg.80]    [Pg.103]    [Pg.192]    [Pg.113]    [Pg.9]    [Pg.786]    [Pg.109]    [Pg.64]    [Pg.83]    [Pg.85]    [Pg.352]    [Pg.198]    [Pg.749]    [Pg.323]   
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Biologic License Application

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