如果您的产品不在CBER的管辖范围内,但受CDER监管,请访问 “研究性新药(IND)申请”,了解有关向CDER提交IND的信息。 (11)问:还有问题吗? 答:pre-IND会议对于申办者获得有关申办者产品开发计划的反馈意见很有价值,尤其是当申办者的问题没有在...
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 ...
•Copy of the meeting request with updates to reflect the most current information 沟通在 pre-IND会议中重要吗?是的,确定有用。 •提出具体、措辞明确的问题 •确定问题的优先次序 •关注议程 •不要隐藏关注点 •不要提供会议资料包中没有的数据 •通过清晰的提问和倾听获取简明扼要的信息 以下...
INTERACT是INitialTargetedEngagement forRegulatoryAdvice onCBER/CDER ProducTs的缩写,该会议类型允许申办方在创新药开发的早期与FDA沟通交流,是早于pre-IND会议的一类会议,目的是解决产品达到IND-enabling之前遇到的问题。 ② 适用范围 ●解决新颖和具有挑战性的问题,如果不解决这些问题,可能会延迟产品进入IND的时间。 ●...
Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (“Algernon”), a clinical stage pharmaceutical development company, is pleased to announce that it has filed a pre-IND (Investigational New Drug) meeting request with the U.S. ...
LAPIX Therapeutics, Inc. today announced the successful outcome of its pre-IND meeting request with the U.S. Food and Drug Administration (FDA).
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...
原文链接:https://fdareporter.com/stories/564153426-cannabics-pharmaceuticals-prepares-to-submit-the-fda-with-a-pre-ind-meeting-request-for-its-proprietary-colon-cancer-drug-candidate-cannabics-rcc-33
1.Pre-Submission Meeting(提交前会议)-申请人有机会讨论和解释将要提交的 ANDA 的格式和内容的会议。 注意:虽然将讨论 ANDA 的拟议内容,但提交前会议将不包括对摘要数据或完整研究报告的实质性审查。 2.Product Development Meetings(产品开发会议)-涉及科学交流的会议,以讨论具体问题(如拟议的研究设计、替代方法或...
In its Pre-IND meeting request, the Company requested regulatory guidance on its planned randomized, multicenter study to evaluate the safety and efficacy of AS1411 in hospitalized patients with COVID-19. The FDA's recommendation is to commence with a Phase 2a...