FDA“间质性膀胱炎/膀胱疼痛综合征:制定治疗药物开发方案的供企业用的指导原则草案”介绍

Introduction to FDA's“Interstitial Cystitis/Bladder Pain Syndrome:Establishing Drug Development Programs for Treatment Draft Guidance for Industry”

美国食品药品管理局(FDA)2023年6月宣布了“间质性膀胱炎/膀胱疼痛综合征:制定治疗药物开发方案的供企业用的指导原则草案”(修订版1)。该修订版取代了FDA于2019年12月发布的“间质性膀胱炎/膀胱疼痛综合征(IC/BPS):确定治疗药物的有效性的供企业用的指导原则草案”。该指导原则修订版,针对治疗间质性膀胱炎/膀胱疼痛综合征(IC/BPS)的药物临床开发的难点,为其临床研究方案提出了许多详细而具体的建议,这些建议有重要的指导意义和参考价值。而我国目前还没有类似的指导原则。详细介绍FDA该指导原则修订版,期望对我国这类药物开发的临床研究和审评有所裨益。

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the"Interstitial Cystitis/Bladder Pain Syndrome:Establishing Drug Development Programs for Treatment Draft Guidance for Industry"(Revision 1)in June 2023.This revised version replaces the"Interstitial Cystitis/Bladder Pain Syndrom:Establishing Effectiveness of Drugs for Treatment Draft Guidance for Industry"issued by FDA in December 2019.The revised version provides many detailed and specific recommendations for the clinical research program of drugs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.