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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food & Drug Administration 1401 Rockville Pike Rockville, MD 20852 From: Mark Levi, Ph.D., OCB/DISC HFM682 Rite Agarwal, Ph.D., OCB/DISC
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The primary review memo analytical is a document that provides analysis and evaluation of the primary review conducted on a subject.
The person or entity responsible for conducting the primary review is required to file the primary review memo analytical.
The primary review memo analytical is typically filled out by providing detailed analysis, findings, and recommendations based on the primary review conducted.
The primary review memo analytical serves the purpose of documenting and communicating the results of the primary review process.
Information such as analysis of primary review findings, evaluation of primary review outcomes, and recommendations for future actions must be reported on the primary review memo analytical.
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