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Notice on Publicly Soliciting Opinions on the "Guiding Principles of Statistics for Clinical Research of Rare Disease Drugs (Draft for Solicitation of Comments)"

 Last Update: 2021-12-06
 Source: Internet
 Author: User

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In order to encourage pharmaceutical companies to develop drugs for the treatment of rare diseases and improve the efficiency and quality of clinical research and development, our center has organized the drafting of the "Rules for Clinical Research of Rare Disease Drugs (Draft for Comment)", which is now open for comments
.

We welcome valuable comments and suggestions from all walks of life, and please give us feedback in time

The time limit for soliciting opinions is 1 month from the date of publication

Please send your feedback to the mailbox: Heng Mingli hengml@cde.

Thank you for your participation and great support

Drug Evaluation Center of the State Drug Administration

November 18, 2021

Appendix:

1 Drafting instructions for "Statistics Guiding Principles for Clinical Research of Rare Disease Drugs (Draft for Solicitation of Comments)".

2 "Guiding Principles of Statistics for Clinical Research of Rare Disease Drugs (Draft for Solicitation of Comments)".

3 "Guiding Principles of Statistics for Clinical Research of Rare Disease Drugs (Draft for Solicitation of Comments)" feedback form for soliciting opinions.
docx

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