ARS Pharmaceuticals Submits Response To FDA Complete Response Letter For Neffy
ARS Pharmaceuticals Submits Response To FDA Complete Response Letter For Neffy
ARS Pharmaceuticals 向 FDA 提交了回复 Neffy
- Response addresses all additional requests in FDA CRL, including positive data from a repeat dose PK/PD study of neffy under nasal allergen challenge (NAC) conditions, and updated testing that detected no measurable nitrosamine levels, conducted per August 2023 FDA Guidance
- Submission of CRL response triggers up to six-month review period by the FDA
- 答复解决了FDA CRL中的所有其他要求，包括来自重复剂量PK/PD研究的阳性数据 neffy 根据 2023 年 8 月 FDA 指导方针，在鼻腔过敏原挑战 (NAC) 条件下进行的最新测试未检测到可测量的亚硝胺水平
- 提交CRL回复将触发FDA长达六个月的审查期
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