Pre-IND会议也可以为申请人提供有效信息,帮助其准备缺陷信息以提交完整的研究性新药申请(IND)。有效地利用FDA的资源可以使药物开发更有效率、加快申报并节约成本。 FDA鼓励但不强制申请人召开Pre-IND会议,通常上讲,FDA会同意大部分的...
The article reports on the pre-Investigational New Drug (IND) meeting requested by Stemedica Cell Technologies Inc. with U.S. Food and Drug Administration in 2009. Said appeal is with regards to the use of allergenic mesnchymal bone marrow cells as the new approach for treatment of ischemic ...
The PIND meeting provided the Arch team with guidance from the FDA for the content of a future IND application for cilastatin. An IND application is a request to the FDA for authorization to administer a new drug to patients in a human trial. The Arch te...
MELBOURNE, Australia, July 02, 2024 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company, is pleased to announce that it has filed a pre-IND (investigational new drug) application with the United States Food and Dru...
Artelo Biosciences, Inc. recently announced it has completed a pre-IND meeting with the US FDA regarding the manufacturing, preclinical, and clinical development plan for ART26.12. Based on the FDA’s feedback, the company also announced it plans to file an IND application for the use of ART...
临床试验申请前会议(pre-IND会议)通常是指创新药进行临床试验前申请人与药监部门沟通交流的会议,申请人可就I期临床试验的问题与药监部门进行沟通。2020年12月11日CDE发布的《药物研发与技术审评沟通交流管理办法》[1]用于指导申请人如何与CDE进行沟通。对于计划向FDA申请IND的申请人,可参考2017年FDA发布的指南《Formal...
[2] KemPharm, Inc. Completes Pre-IND Meeting with FDA for NME Prodrug of Hydromorphone, KP511....
NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V) (the “Company” or “NurExone”) is pleased to announce that the Company has completed a Pre-Investigational New Drug (“Pre-IND”) meeting with the U.S. Food and Drug Administratio...
“The successful completion of the pre-IND meeting process with the FDA for KP1077 affirms our plan to submit the IND application by mid-year 2022 and, following that, potentially initiate a Phase 2 trial of KP1077 in IH as early as the third quarter of 2022,” stated Travis Mickle, Ph...
2021年10月18日,一家临床阶段的制药公司Alphageneron Pharmaceuticals宣布,该公司成功与FDA完成了针对其自体NK细胞疗法治疗晚期非小细胞肺癌(NSCLC)临床试验计划的pre-IND会议。 此次讨论的候选疗法名为ENKASTIM,是一种靶向mHsp70的自体NK细胞疗法,可激活NK细胞以靶向并杀死表达mHsp70的细胞。