OTP INTERACT Meetings - FDA
2024年8月22日 · For additional details on a development program’s qualification for INTERACT, how to request and where to send the meeting request for products regulated in OTP/CBER, please see SOPP 8101.1:...
FDA 会议系列指南（INTERACT 会议） | 创思立信 - EC Innovations
INTERACT（INitial Targeted Engagement for Regulatory Advice on CBER producTs）会议是创新研类生物制品的申办方与 CBER 之间举行的非正式会议，旨在从 FDA 获得关于CMC、药理学/毒理学和/或临床方案方面的非约束性建议。
There are six types of formal meetings under PDUFA that occur between requesters and FDA staff: Type A, Type B, Type B (end of phase (EOP)), Type C, Type D, and Initial Targeted Engagement for...
The INTERACT meeting allows sponsors to obtain preliminary informal feedback on CMC, Non-clinical, and Clinical issues for innovative investigational products earlier in development than the pre-IND stage. Unlike pre-IND meetings, there is no Prescription Drug User Fee Act (PDUFA) mandated date for FDA to schedule the INTERACT meeting, and you ...
FDA INTERACT meetings - Cardinal Health
Although all FDA meetings play a critical role in any sponsor’s development strategy, when it comes to cell and gene therapies, the most valuable FDA interaction is arguably the very first: the INTERACT meeting. During the INTERACT meeting, sponsors can obtain initial, nonbinding advice from FDA regarding chemistry, manufacturing and controls ...
meeting. Key Takeaways • An INTERACT meeting may be your first interaction with FDA if you have a novel product/development program . It can be highly beneficial, helping you identify the data required for to support a pre-IND meeting request and potentially conserving time and funds.
FDA更新创新药正式沟通交流会议指南 - 知乎 - 知乎专栏
2017年版的指南草案仅包括了4种会议类型，即Type A、Type B、Type B (End of phase (EOP))和Type C，而2023年版指南草案在2017版的基础上增加了Type D和 INTERACT两类会议。 为了让读者能更清晰的了解各类会议的差异，笔者将从会议适用范围、会议申请流程及时限等进行了对比，详见下表。 （点击下方图片即可放大查看） 美国创新药涉及的沟通交流会议，大致流程分为会议申请、会议准许（递交整套资料）、初步意见、召开会议、发送 会议纪要 5个阶段，笔者对 …
奥来恩专家解读 | 细胞和基因治疗产品如何在研发早期获得FDA的 …
INTERACT会议是FDA CBER人员与申请人之间沟通交流的一种会议形式，目的是针对在研产品处于研发早期阶段但尚未到Pre-IND阶段的问题，提供初步的非正式、非约束性咨询。 在今年6月19日于美国费城举办的SAPA“细胞和 基因治疗 年会”上，FDA生物制品评价与研究中心（Center of Biologics Evaluation and Research，CBER）主任Peter Marks博士做了题为“FDA’s Efforts to Facilitate the Development of Cell and Gene Therapies”的会议主题报告。
Interactions with Office of Therapeutic Products | FDA
2024年8月22日 · INTERACT Meeting. INTERACT or an INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs meeting is an opportunity for sponsors developing novel therapies to request...
Through an INTERACT meeting, sponsors can obtain initial, non-binding advice from FDA regarding chemistry, manufacturing and controls, pharmacology/toxicology, and/or clinical aspects of the development program.