Get the free Final Review Addendum to CMC Review of BPLs Resubmission to BLA - COAGADEX - fda

FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH MEMORANDUM To: File (STN BL 125506/0) & Patina Reyna From: Mikhail V. Vanessa, PhD, Visiting Scientist, Laboratory of Hemostasis

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6. State the specific updates or additional information being added in the addendum. Use clear and succinct language to convey the intended message.
7. If necessary, provide any supporting evidence or documentation to validate the information presented in the addendum.
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10. Finally, safely store a copy of the final review addendum for future reference and record-keeping purposes.

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