包括会议申请(Meeting request)和会议资料(Meeting package),INTERACT与pre-IND会议不同的是,需要同时提交Meeting request和package文件。INTERACT会议资料要简洁,不超过50页。申请会议资料所需要包括的信息与其他Type A,B,C会议相似。主要内容需要包括产品介绍、疾病背景介绍、咨询的问题和申办方对该问题的意见等。 ⑥ ...
INTERACT会议无意取代PIND会议,PIND会议在提交IND之前举行,讨论产品计划中的初步研究的范围和设计、支持人体临床试验所需的动物研究的设计以及IND的格式。相反,INTERACT 会议也不能向尚未启动任何产品开发活动的申办方提供建议(即需要有一些初步...
INTERACT会议无意取代PIND会议,PIND会议在提交IND之前举行,讨论产品计划中的初步研究的范围和设计、支持人体临床试验所需的动物研究的设计以及IND的格式。相反,INTERACT 会议也不能向尚未启动任何产品开发活动的申办方提供建议(即需要有一些初步的研究或衍生的研究计划)。在要求召开 INTERACT 会议之前,申办方需要选择特定的...
关于特定的CGT产品开发状态对于申请INTERACT会议是否为时过早或过于超前的考虑因素可见FDA网页。关于开发计划的INTERACT资格确认、如何申请 INTERACT会议以及将会议申请发送到何处的更多详细信息,请参阅FDA 的“SOPP 8101.1:与药品和生物制品申请人和...
If a written response only (WRO) has been requested or the FDA chooses to provide WRO, the FDA will respond to the meeting request with the date they intend to send the written responses to the sponsor, generally 70 days from the meeting request receipt date. FDA will entertain requests fo...
Such drugs include (1) estrogenic, androgenic, or thyroid hormones, (2) drugs that are based on these hormones (e.g., estrogen derivatives), and (3) drugs that are not based on these hormones but that have the potential to interact with E, A, or T hormone pathways (e.g., aromatase...
How to interact with the investigator-DO's and DON'T's What companies should do when the inspection ends How to reply to 483's and warning letters Legal implications of non-compliance Why inspections are conducted and by what statutory authority ...
Sponsors may also choose to interact with FDA staff via a type of Q-Submission known as an “Informational Meeting” to provide general information and an overview of new or novel device types, without expectation of FDA feedback. Special programs Novel and rapid therapies may qualify for, and...
Donald Karcher, president of the College of American Pathologists, said most LDTs are developed and used for patients that are cared for in the hospital or health care network where the lab is located, which enables the lab and pathologists to interact directly to adequately assess the clinical ...
CBER had previously, as recently as July 2024 in its SOPP on regulatory interactions with sponsors (SOPP 8101.1), described that an INTERACT meeting may be appropriate when a sponsor has identified a “specific investigational product or product-derivation strategy to evaluate in a clinical study ...