Pre-IND会议也可以为申请人提供有效信息,帮助其准备缺陷信息以提交完整的研究性新药申请(IND)。有效地利用FDA的资源可以使药物开发更有效率、加快申报并节约成本。 FDA鼓励但不强制申请人召开Pre-IND会议,通常上讲,FDA会同意大部分的...
发起人与CDER或CBER间召开会议的目的随着临床试验阶段的改变而发生改变，Pre-IND会议的目的是审查初次进行...
1.本 SOPP适用于研究性新药(IND)、仿制药/新药申请(A/NDA)、生物制品许可申请(BLA)及其各自的预先提交(pre-submissions)、修订(amendments)和补充(supplements)的会议提交。 2.本 SOPP适用于《生物类似药用户付费法》Biosimilar User Fee ...
1.本 SOPP适用于研究性新药(IND)、仿制药/新药申请(A/NDA)、生物制品许可申请(BLA)及其各自的预先提交(pre-submissions)、修订(amendments)和补充(supplements)的会议提交。 2.本 SOPP适用于《生物类似药用户付费法》Biosimilar User Fee Act(BsUFA)、Generic Drug User Fee Act《仿制药用户付费法》(GDUFA)和《...
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。
Before submitting a Type A meeting request, requesters should contact the review division or office to discuss the appropriateness of the request. B. Type B Meeting Type B meetings are as follows: ●Pre-investigational new drug application (pre-IND) meetings. ...
美国FDA 指导原则 IND提交的个体化反义寡核苷酸药物产品管理和程序建议 英文原版 35165469dft.docx 12/29/20IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators DRAFT GUIDANCE This guidance document is being ...
(FDA) in response to Qu’s first Pre-IND meeting package submission. The FDA provided informative feedback on important product development questions related to manufacturing, clinical trials and non-clinical testing that will guide Qu in its QBECO SSI development pro...
early phase study designs, and statistical analysis plans when preparing a pre-IND meeting package. In addition to these topics, the guidance also addresses expedited programs for serious conditions, companion diagnostics, orphan drug product incentives, pediatric studies, and data standards and electroni...
therapies to treat progressive kidney disease, is pleased to announce that the Company has received a positive response from the U.S. Food and Drug Administration (“FDA”) regarding its recent submission of a COVID-19 coronavirus pre-i...