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JChoi

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32952b3 almost 2 years ago

April 20, 2023 Approval Letter COMIRNATY.txt
3.4 kB

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August 23, 2021 Approval Letter - Comirnaty.txt
23.5 kB

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August-25-2022-Approval-Letter-COMIRNATY.txt
3.41 kB

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Benefit-Risk Assessment Review Memo - COMIRNATY.txt
57 kB

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Bioresearch Monitoring Discipline Review Memo, August 13, 2021 - COMIRNATY.txt
4.94 kB

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CBER CMC BLA Review Memo - COMIRNATY.txt
148 kB

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CBER Sentinel Program Sufficiency Memo - COMIRNATY.txt
14.8 kB

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CMC Review Memo, August 21, 2021 - COMIRNATY.txt
82.6 kB

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Clinical Review Memo, August 23, 2021 - COMIRNATY.txt
308 kB

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December 16, 2021 Approval Letter - Comirnaty.txt
3.78 kB

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Employee-Officer List Memo, August 22, 2021 - COMIRNATY.txt
1.53 kB

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July-8-2022-Approval-Letter-COMIRNATY.txt
4.57 kB

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July-8-2022-Clinical-Review-Memo-COMIRNATY.txt
168 kB

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November 8, 2021 Summary Basis for Regulatory Action - Comirnaty.txt
71.6 kB

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Package Insert – COMIRNATY (gray cap).txt
65.2 kB

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Package Insert – COMIRNATY (purple cap).txt
68.9 kB

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Pharmacovigilance Plan Review Memo - COMIRNATY.txt
84.7 kB

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Pharmacovigilance Plan Review-Addendum Memo - COMIRNATY.txt
22.2 kB

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Real World Evidence BLA Memo - COMIRNATY.txt
14.9 kB

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Statistical Review - COMIRNATY.txt
59.6 kB

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Statistical Review -- COMIRNATY.txt
11.7 kB

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Statistical Review-COMIRNATY.txt
32 kB

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Statistical-Review-COMIRNATY.txt
36.7 kB

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Toxicology Review - COMIRNATY.txt
186 kB

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