2020年4月17日 · Established in 1988, the Office of Antimicrobial Products (OAP) Pre-Investigational New Drug Application (Pre-IND) Consultation Program is designed to facilitate and foster early...

2024年8月22日 · A Pre-IND Meeting can also provide information that will assist sponsors in preparing to submit complete investigational new drug (IND) applications and reduce the risk of a clinical hold.

2024年10月1日 · The pre-Investigational New Drug (pre-IND) meeting with the FDA is a crucial step in the drug development process. It provides an opportunity for sponsors to seek critical feedback on their development plans and clarify regulatory …

A sponsor may consult with the Agency before formal submission of an IND application and send a pre-IND meeting request (PDF - 145KB) to an appropriate Review Division responsible for...

pre-ind会议是指申请者在递交ind申请前，自愿递交与fda共同召开会议申请的一种会议。 FDA鼓励召开，但不强制要求（不是所有的IND申请都有必要召开Pre-IND会议，简单的临床试验可不必召开Pre-IND会议）。

2022年5月12日 · The pre-IND meeting is usually a drug sponsor’s first formal meeting with the FDA as they begin the process of bringing a drug to market. The meeting provides sponsors the opportunity to discuss their IND plans prior to the full IND submission.

The pre-IND meeting is a unique opportunity to meet with the FDA to discuss questions about your program and to help ensure a complete IND application is submitted. The pre-IND meeting is free of cost and can help avoid clinical holds and costly missteps.

2023年4月24日 · 2023年3月31日，CDE举办了“药品注册研发沟通交流主题线上宣讲会”，分享了沟通交流机制及常见问题等。今天此篇文章将在沟通交流管理办法的基础上，结合本人近期的实际操作经验，详细介绍创新药首次临床试验申请前即 Pre-IND会议 资料的准备。不足之处，还 ...

2024年9月24日 · Get expert tips on preparing a successful investigational new drug (IND) application, from pre-IND meetings to crafting compelling nonclinical summaries. Maximize your chances of regulatory success with these best practices.

2024年12月12日 · The purpose of a pre-IND meeting is to discuss important details about the design pre-clinical studies (especially IND-enabling toxicology studies), and to discuss product manufacturing and quality control measures needed to conduct human studies.