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...

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11月18日 · CDER's Pre-Investigational New Drug Application (IND) Consultation Program fosters early communications between sponsors and new drug review divisions to provide guidance on the data...

2024年10月1日 · The pre-IND meeting is a formal engagement, mandated by the Prescription Drug User Fee Act (PDUFA), designed to facilitate dialogue between the FDA and sponsors. It serves as a platform for sponsors to discuss their development programs and seek guidance on scientific and regulatory matters.

2022年5月12日 · There are three categories of formal FDA meetings: Types A, B, and C. Most pre-IND meetings are Type B meetings, and occur at predefined time points. For a pre-IND meeting, there are three meeting formats: face-to-face, teleconference, or …

临床试验申请前会议 (pre-IND会议)：通常是指创新药进行临床试验前申请人与药监部门沟通交流的会议。 新药临床试验 (Investigational new drug, IND)申请：一般是指尚未经过上市审批，正在进行各阶段临床试验的新药。

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.

The pre-IND meeting can be helpful in developing a strategy for drug development by Identifying studies that will support the initiation of clinical trials; Discussing available methods to...

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.

2015年5月29日 · The Pre-IND Process: Do You Need an IND? Review the five requirements below to determine if your study qualifies for exemption from an IND (21 CFR 312.2). Still not sure? Start with the IND Decision Tool. Pay particular attention to requirement #3.

2022年2月22日 · IND — The IND (investigational new drug application) is the vehicle through which a sponsor advances to the next stage of drug development known as clinical trials (human trials)....

依据 《国家药品监督管理局关于调整药物临床试验审评审批程序的公告》：申请人在提出新药首次药物临床试验申请之前，应向药审中心提出沟通交流会议申请。 其中，在申请人递交IND申请前，可 自愿 进行一次重要的会议，即Pre-IND会议。 可在临床研发不同阶段提出沟通交流申请，沟通交流会分为 I类、II类、III类 三种会议类型，每类会议针对不同情况开展， Pre-IND会议 属于 …

Pre-IND meetings with the FDA represent a valuable source of insight and feedback for any investigational new drug (IND) applicant. These optional meetings offer many benefits, but it is important to understand the application requirements, timeline, and meeting format in order to obtain the most benefit from these opportunities.

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 ...

2021年9月29日 · What is a pre IND meeting FDA? Pharmaceutical companies that are going through the IND application process are allowed to have meetings with the FDA to discuss the development and review of their applications. The meeting is …

2017年1月11日 · The pre-IND meeting represents a critical point in the regulatory process and remains one of the near-guaranteed opportunities to obtain valuable FDA feedback, while establishing a strong relationship with the agency.

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...

2022年9月27日 · Understand the requirements for Pre-IND (PIND) meetings with CBER so you can get prepared, including a timeline for Type B PIND meetings.

2017年12月15日 · For those developing a new biologic or pharmaceutical product, Pre-Investigational New Drug Application (pre-IND, PIND) meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies.

2022年1月7日 · 本文将介绍如何在新药I期临床试验前向FDA申请pre-IND会议，其流程与要求如下: FDA Pre-IND会议主要审查药学研究与非临床试验试验研究，并讨论现有研究结果是否足以支持开展临床研究；讨论I期临床试验范围及设计方案；新药儿童药物研究计划；IND注册申请数据的最佳呈现方式等 [3]。 它可以减少临床试验暂停（clinical hold）的发生，并协助申请人更顺利地开 …