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Marianne Armstrong PhD 415 466-2532 James L. McVey Conclusion This is a review of a response to an information request letter. Recommendations A. B. Approvable N/A Summary of Microbiology Assessments Brief Description of the Manufacturing Processes that relate to release testing program. The CR Letter cited issues with the sample size used in the assay. The Applicant has responded by modifying the method to permit an increase in sample size for analysis. D. Senior VP Regulatory Affairs and...
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