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    FDA Capvaxive (BLA 125814) Review Documents Including Summary Basis and Multiple Memoranda

    FDA Capvaxive (BLA 125814) Review Documents Including Summary Basis and Multiple Memoranda

    $89.00 USD
    $89.00 USD
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    Original Request: I am requesting release of the following Capvaxive FDA review documents for BLA 125814: 1. Summary Basis for Regulatory Action June 17, 2024 2. Analytical Review Memorandum 3. BLA Clinical Review Memorandum 4. CBER BLA Device Review Memorandum 5. CBER CMC BLA Review Memorandum 6. CBER DMPQ CMC Facility BLA Review Memorandum 7. Final DBSQC/OCB Analytical Method Review Memorandum 8. Review of Analytical Methods Pneumococcal 21-valent conjugate vaccine 9. Review of Hemagglutinin Inhibition (HI) Assay Method and Validation 10. Chemistry, Manufacturing and Controls Statistical Review 11. Toxicology Review of Pneumococcal 21-Valent Conjugate vaccine Please provide the documents electronically if possible.
    Tags: MedTech, BLA, 2024
    • Status: Pending Fast-Track Request
    • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

    NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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