FDA IND: Pharmacology and Toxicology (PT) Information1.IND Applications for Clinical Investigations: Pharmacology and Toxicology (PT) InformationThis component of an IND application is expected to contain information about pharmacological and toxicological (laboratory animals or in vitro) studies on the ba...
Regulations repeatedly describe this section as brief. Ordinarily, two to three pages should suffice. The information requested here is intended to place the developmental plan for the drug into perspective and to help FDA anticipate sponsor needs. Often a sponsor in the first human studies is simp...
Regulations repeatedly describe this section as brief. Ordinarily, two to three pages should suffice. The information requested here is intended to place the developmental plan for the drug into perspective and to help FDA anticipate sponsor needs. Of...
the IND sponsor is required to submit Information Amendments, with additional PT information pertinent to safety or other aspects of the IND application.
5.MAPP6030.1:IND Process and Review Procedures (including Clinical Holds) 在美国,IND(Investigationalnewdrug)分为2种:商业IN 二、 Pre-IND 和IND申请流程 Pre-IND 属于type B,申请后21个自然日FDA回复是否同意召开会议,如同意,申请后60个自然日召开会议,会议30个自然日前提交Pre-IND会议资料。
IND Application Procedures: Exemptions from IND Requirements IND申请程序-免除IND要求 在提交IND申请之前,研究者应参考《临床研究者、申请人/赞助商和IRB指南》-新药研究申请(IND)--以确定临床试验是否可以在不提交IND申请(豁免)的情况下进行。 如果符合第312.2(b)节中的所有豁免标准,则上市药物的临床研究可免于IND...
FDA IND: Pharmacology and Toxicology (PT) Information 1.IND Applications for Clinical Investigations: Pharmacology and Toxicology (PT) Information This component of an IND application is expected to contain information about pharmacological and toxicological (laboratory animals or in vitro) studies on the...
研究性新药申请(IND)是临床研究申办者向美国食品药品管理局(FDA)提出的申请,以获得对人体使用研究性药物或生物制品的授权。临床研究通常用于收集安全性和有效性信息,以支持生物制品和药物产品的上市申请。除非获得豁免,否则临床研究的申请人必须通过提交IND申请( submitting an IND Application)获得FDA的授权才能开展研究。
《Fast Track Drug Development Programs:Designation, Development and Application Review》)等指南加深了发起人对会议的理解;CDER的《政策和程序手册》(《Manual of Policy and Procedures》)中与正式会议相关的政策和程序,CBER的《标准运营程序和政策》(《Standard Operating Procedures and Policies》)第8101.1条也有助...
If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. INTRODUCTION This guidance document provides to you, sponsors of an investigational device exemption application (IDE) or an investigational new drug application (IND), ...