需要明确的是,PPT应简洁明了,它是对沟通交流会议资料的充分提炼与展示,需要把讨论的问题、支持性数据以及申请人意见描述清楚,突出重点。沟通交流PPT,作为Pre-IND meeting 的重要一环,很多圈友们想知道到底该如何呈现呢?笔者近期整理了一个化药创新药Pre-IND meeting PPT模板,供圈友们参考,不足之处还请指正!PS:...
目前已召开多次臨床试验前会议(pre-IND meeting),讨論国产新药或跨国性 早期臨床试验之谘询案件。对於国产新药之研发,本中 …www.docin.com|基于4个网页 2. 预备会议 选出重点,作出总结 并与 CBER联络,要求召开一次新药申请的预备会议 (Pre-IND meeting)。预备会议的目的 是使 CBER的有关人员 …read.cuc...
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 ...
3.2 Pre-IND Meeting Request What information should be included in the meeting request? Sponsors should review the guidance Formal Meetings with Sponsors and Applicants for PDUFA Products (PDF - 30KB) for information on ...
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...
It states that the said meeting aims to discuss toxicology, pharmacology, and clinical plans for its Advaxis PSA drug for prostate cancer. In addition, Advaxis also plans to submit IND application to initiate Phase I/II safety study of the drug in humans by the end of 2011....
LAPIX Therapeutics, Inc. today announced the successful outcome of its pre-IND meeting request with the U.S. Food and Drug Administration (FDA).
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...
In the meeting request application, the Company is asking for direction regarding the use of DMT as an adjunctive treatment with constraint-induced movement therapy (CIMT) for the treatment of upper-limb dysfunction in stroke patients. Another pre-IND meeting...
is pleased to announce that the U.S Food and Drug Administration (U.S. FDA) granted the Company’s request for a pre-IND (Investigational New Drug) meeting to discuss the novel therapy and proprietary protocol of SANA-013 for the treatment of Traumatic Brain Injury (TBI) related major depr...