Requiring a certification (Form FDA 3674) to accompany certain applications and submissions submitted to FDA is, therefore, one way of encouraging compliance with the provisions of the …

2022年3月31日 · Form FDA 3674 (PDF - 3MB): Certification of Compliance; Form FDA 3454 (PDF - 47KB): Certification: Financial Interests and Arrangements of Clinical Investigators

· Form FDA 3674 (PDF - 3MB): Certification of Compliance,合规性认证表格是FDA要求申请人在提交新药或医疗器械申请时填写的一份表格。它用于确认申请人的产品在制造和分销过程中符合 …

certification form (Form FDA 3674) to be used to satisfy the certification requirement. The Form FDA 3674 can be obtained at:

Form 3674 must accompany an application/submission, including certain amendments, supplements, and resubmissions, submitted under §§ 505, 515, 520(m), or 510(k) of the …

2018年11月12日 · 3674表格，需要登录美国NIH的Clinical Trials.gov网站，获得登记号，将此号填入3674表。 也就是说，所有FDA的临床试验都要求在Clinical Trial.gov登录。 首页函 （cover …

The Form FDA 3674 is a document that must accompany the initial submission, and when submitting a new protocol to IND. It is a signed statement from the sponsor that they will …

This page provides links to commonly used clinical trial forms relevant to clinical trials. For other FDA forms, visit the FDA Forms page.

2025年3月11日 · The FDA form 3674 is a document that must accompany all FDA IND initial submissions and submission of new protocols to INDs. It is a signed statement from the …

IND申请主要基于2个目的：1.提供数据表明初始用于人体 FIH 的安全合理性；2.该药物是否具有药理活性，具备商业可开发性。 IND审评主要基于受试者安全性和权益，使研究性药物能跨州运 …