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CDE publishes ICH E11A: Pediatric Extrapolation guidelines for comments.

 Last Update: 2022-10-01
 Source: Internet
 Author: User

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Source: CDE website

The ICH E11A: Pediatric Outreach guidelines are now in Phase 3 of the Regional Public Comment Phase
.

The original English and Chinese translations of the draft E11A Guiding Principles are attached hereto, and the content of the Guiding Principles and the translation Chinese are hereby open to the public for comments
.

If there are any relevant suggestions from all walks of life (fill in Attachment 3), please feedback to our center
by contact email before July 30, 2022.

Contacts: Geng Ying, Zhai Yun

Email: gengy@cde.

Appendix 1: E11A: Pediatric Extrapolation (Draft)

Appendix 2: [Chinese] E11A: Pediatric extrapolation (draft)

Appendix 3: [Template] Feedback Form for Solicitation of Comments

Drug Evaluation Center of the State Drug Administration

April 25, 2022

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