●It is a Type B meeting, which means FDA will schedule the meeting within 60 calendar days of a meeting request. ●FDA will grant most pre-IND meetings; however, they will generally only schedule one pre-IND m...
Arch Biopartners Inc. recently announced it had a pre-investigational new drug application (PIND) meeting with the US FDA Division of Cardiovascular and Renal Products (DCRP) on February 23, 2024, to discuss Arch’s plan to repurpose cilastatin as a new trea...
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...
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...
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 ...
[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...
FDA的沟通会议之⼀：Pre-IND会议 为解决临床试验过程中出现的问题，FDA与发起⼈可以经常召开会议。在资源许可范围 内，FDA⿎励召开有助于药品审评以及解决药品相关科学问题的会议。召开会议的总体原则是 公开、全⾯、⾃由交流可能在临床试验过程中出现的任何科学或医疗问题。上述会议应根据 CFR 21章第10部分...
“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...
根据发起人和FDA在会议上需讨论的CMC问题的范围,可把以上四种会议的召开形式分为两种:多学科会议(Multidisciplinary Meeting)和CMC特定会议(CMC-Specific Meeting)。多学科会议是指,在临床试验前召开的会议,或处于临床试验期间召开的会议,这些会议大多数是以多学科交叉的方式召开的,范围涉及了临床学、药理学、药代动力学...