Document text
From: Smith, Michael (CBER)
Sent: Tuesday, August 10, 2021 1:11 PM
To: 'Aghajani Memar, Neda' <[email protected]>; 'Harkins Tull, Elisa'
<[email protected]>; 'Devlin, Carmel M' <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected] ov>
Subject: STN 125742.0: Testing related IR
Neda,
The review team has the below testing related IR and they have requested a response by Wednesday, August 11, 2021.
Please provide the established and polydispersity
index lim its for the control lot of PF -07302048- DP-RM for the test of “Size and
polydispersity Index Measurement in mRNA LNP Samples by Dynamic Light Scattering” for drug product.
Regards,
Mike
- Please confirm receipt of this e -mail and let us know if you have any
questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration
Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applications
Tel: 301- 796-2640
[email protected]
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FDA-CBER-2021-5683-1150236
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FDA-CBER-2021-5683-1150237