美國(guó)食品藥品監(jiān)督管理局（FDA）于2022年4月發(fā)布了“乳糜瀉：開(kāi)發(fā)無(wú)麩質(zhì)飲食輔助治療藥物供企業(yè)用的指導(dǎo)原則（草案）”。該指導(dǎo)原則草案提出了無(wú)麩質(zhì)飲食輔助治療藥物臨床試驗(yàn)方案的建議，詳細(xì)說(shuō)明了開(kāi)發(fā)這類藥物臨床試驗(yàn)關(guān)鍵要素的許多具體建議，包括試驗(yàn)人群、試驗(yàn)設(shè)計(jì)、療效及安全性評(píng)估等方面。而我國(guó)目前尚沒(méi)有類似的指導(dǎo)原則。詳細(xì)介紹FDA該指導(dǎo)原則草案主要內(nèi)容，期望對(duì)我國(guó)這類藥物開(kāi)發(fā)的臨床研究及其監(jiān)管有幫助。

The U. S. Food and Drug Administration (FDA) published in April 2022 "Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet Guidance for Industry (Draft)." The draft guideline puts forward recommendations for clinical trial protocols for gluten-free dietary adjuvant therapeutic drugs, detailing many specific recommendations for the development of key elements of clinical trials of such drugs, including trial population, trial design, efficacy and safety evaluation, etc. China currently does not have similar guidelines. Introduce the draft guideline of FDA in detail, hoping to be helpful to the clinical research and supervision of the development of such drugs in China.

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