Document text
From: Smith, Michael (CBER)
Sent: Wednesday, June 9, 2021 2:12 PM
To: 'Harkins Tull, Elisa' <[email protected]>; 'Aghajani Memar, Neda' <[email protected]>;
'Devlin, Carmel M' <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected] ov>
Subject: STN 1275742.0: Request for dates associated with PREA deferred studies
Elisa,
The clinical team has an information request regarding the dates associated with the PREA deferred studies – see below. Please submit this information to the BLA by Friday, June 18
th.
Please provide the following dates for your PREA deferred studies: Study C4591001: Ages 12 Through 17 Years
Final Protocol Submission: xx -xx-xxxx
Study Completion: xx -xx-xxxx
Final Report Submission: xx -xx-xxxx
Study C4591007: 11 years of age and younger
Final Protocol Submission: xx -xx-xxxx
Study Completion: xx -xx-xxxx
Final Report Submission: xx -xx-xxxx
Regards,
Mike
- Please confirm receipt of this e -mail
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-2021-5683-1024680