2021/0825-1 2021年8月25日 #健康
正式商人はまだなのか？
Page 5 – STN BL 125742/0 – Elisa Harkins
Your deferred pediatric studies required under section 505B(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) are required postmarketing studies. The status of these postmarketing studies must be reported according to 21 CFR 601.28 and section 505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to report annually on the status of any postmarketing commitments or required studies or clinical trials.
Label your annual report as an “Annual Status Report of Postmarketing Study Requirement/Commitments” and submit it to the FDA each year within 60 calendar days of the anniversary date of this letter until all Requirements and Commitments subject to the reporting requirements under section 506B of the FDCA are released or fulfilled. These required studies are listed below:
1. DeferredpediatricStudyC4591001toevaluatethesafetyandeffectivenessof COMIRNATY in children 12 years through 15 years of age.
Final Protocol Submission: October 7, 2020 Study Completion: May 31, 2023
Final Report Submission: October 31, 2023
2. DeferredpediatricStudyC4591007toevaluatethesafetyandeffectivenessof COMIRNATY in infants and children 6 months to <12 years of age.
Final Protocol Submission: February 8, 2021 Study Completion: November 30, 2023
Final Report Submission: May 31, 2024
3. DeferredpediatricStudyC4591023toevaluatethesafetyandeffectivenessof COMIRNATY in infants <6 months of age.
Final Protocol Submission: January 31, 2022 Study Completion: July 31, 2024
Final Report Submission: October 31, 2024
Submit the protocols to your IND 19736, with a cross-reference letter to this BLA STN BL 125742 explaining that these protocols were submitted to the IND. Please refer to the PMR sequential number for each study/clinical trial and the submission number as shown in this letter.
Submit final study reports to this BLA STN BL 125742. In order for your PREA PMRs to be considered fulfilled, you must submit and receive approval of an efficacy or a labeling
Page 6 – STN BL 125742/0 – Elisa Harkins
supplement. For administrative purposes, all submissions related to these required pediatric postmarketing studies must be clearly designated as:
• Required Pediatric Assessment(s)
We note that you have fulfilled the pediatric study requirement for ages 16 through 17
years for this application.
POSTMARKETING REQUIREMENTS UNDER SECTION 505(o)
https://www.fda.gov/media/151710/download?fbclid=IwAR2sYxsKYECrZHV2Wbdwh_iAENjwYepQIkErm3DATjIsis9X-KPDgZVlQ5M