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 提交了回覆 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
- 答覆解決了FDA CRL中的所有其他要求，包括來自重複劑量PK/PD研究的陽性數據 neffy 根據 2023 年 8 月 FDA 指導方針，在鼻腔過敏原挑戰 (NAC) 條件下進行的最新測試未檢測到可測量的亞硝胺水平
- 提交CRL回覆將觸發FDA長達六個月的審查期