BLA is a request for permission to introduce, or deliver for
introduction, a biologic product into interstate commerce. Information
about raw materials, manufacturing process and controls, pre-clinical
and clinical studies should be included. The following is a list of
FDA's review and approval process:
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IND package
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Clinical studies data analysis and results
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Labeling
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FDA inspection of manufacturing facilities and main clinical trial sites
Application requirement:
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IND package
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Phase I to III clinical trial data
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Side effect reporting
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Labeling
Service
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Preparing and organizing Pre-BLA meeting
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Raw materials and products
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Process and control
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Preclinical trial data
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Clinical trial data
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Correspondence with FDA and holding Pre-BLA meeting
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Rectification according to FDA抯 advices
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Preparing and submitting BLA package
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Preparing and organizing BLA data
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BLA drafts review and final versions
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Submitting BLA to FDA as the US agent
Link to "Services" for more information.
