美國食品藥品管理局（FDA）2023年6月宣布了“間質(zhì)性膀胱炎/膀胱疼痛綜合征：制定治療藥物開發(fā)方案的供企業(yè)用的指導(dǎo)原則草案”（修訂版1）。該修訂版取代了FDA于2019年12月發(fā)布的“間質(zhì)性膀胱炎/膀胱疼痛綜合征（IC/BPS）：確定治療藥物的有效性的供企業(yè)用的指導(dǎo)原則草案”。該指導(dǎo)原則修訂版，針對治療間質(zhì)性膀胱炎/膀胱疼痛綜合征（IC/BPS）的藥物臨床開發(fā)的難點，為其臨床研究方案提出了許多詳細而具體的建議，這些建議有重要的指導(dǎo)意義和參考價值。而我國目前還沒有類似的指導(dǎo)原則。詳細介紹FDA該指導(dǎo)原則修訂版，期望對我國這類藥物開發(fā)的臨床研究和審評有所裨益。

The Food and Drug Administration (FDA) announced the "Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment Draft Guidance for Industry" (Revision 1) in June 2023. This revised version replaces the "Interstitial Cystitis/Bladder Pain Syndrom: Establishing Effectiveness of Drugs for Treatment Draft Guidance for Industry" issued by FDA in December 2019. The revised version provides many detailed and specific recommendations for the clinical research program of drugs for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS), addressing the difficulties in clinical development. These recommendations have important guiding significance and reference value. However there is currently no similar guidance in China. This article provides a detailed introduction to the revised version of the FDA guidance, hoping to be beneficial for clinical research and evaluation of this type of drug development in China.

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