网页Learn about the different types of formal meetings between FDA and industry, such as Type D, Type X, Type Y, and Type Z, and their goal dates and formats. Find out the latest updates...
OTP Type D Meetings | FDA - U.S. Food and Drug Administration
网页Learn about the criteria, timelines, and best practices for requesting and conducting Type D meetings with OTP, a division of FDA that reviews cellular and gene therapy products. Type D...
网页This document provides guidance for scheduling and conducting meetings between FDA and industry or sponsor-investigators for drugs and biological products. It includes definitions, policy,...
What You Need to Know About the New FDA Type D Meeting
网页2022年11月16日 · The FDA introduced a new Type D meeting in 2022 that focuses on a narrow set of issues and requires a faster response. Learn the criteria, benefits and limitations of this meeting type and how to request it.
Mastering FDA's Type D meetings: A Comprehensive Guide
网页Learn how to use the Type D meeting format under PDUFA VII to get faster and focused feedback from the FDA on specific topics. Find out the main features, requirements, and possible challenges of this new format and get expert tips for success.
Prescription Drug User Fee Act (PDUFA) VII and Type D Meetings
网页2022年10月12日 · Learn about the proposed Type D meetings under PDUFA VII, which aim to address focused issues on a shorter timeline than other meeting types. Find out the criteria, timelines, and future updates for this new mechanism for interacting with FDA.
FDA会议系列指南（D类会议） - Voisin Consulting Life Sciences
网页D类会议是申办方与CDER或CBER之间举行的正式PDUFA会议。 该会议针对有限数量的议题进行讨论， 一般不会超过2个重点主题。 此外，D类会议要求申办方参会人员来自 不超过3个不同学科或部门。 D类会议中的议题可包括以下方面: 在正式会议中提出的新议题的相关后续问题。 申办方针对一个仅包含数个问题的小规模议题寻求监管机构建议。 关于尖端创新研发方向的问题，该类问题一般不需要监管机构给出深入或者细节性的建议。 会议时间. D类 …
FDA guidance on formal meetings adds new categories, timelines
网页The FDA has revised its draft guidance on different types of meetings for sponsors of drug and biologic products. It adds a Type D meeting for narrow topics and INTERACT meetings for novel products, and classifies video conference meetings as …
FDA Brings its Formal Meetings Guidance Up to Date: What You …
网页2023年9月28日 · Learn about the latest changes and updates on FDA's formal meetings for drug and biologic products, including Type C, Type D, INTERACT, and other meeting formats. Find out the eligibility, scope, timelines, and expectations for each meeting type and how to request them.
Early FDA Feedback With Type D Meetings | Premier Consulting
网页2023年10月1日 · Learn what a Type D meeting is, how to request one, and what are the benefits and limitations of this new format under PDUFA VII. A Type D meeting is a focused and fast way to get FDA questions answered within 50 calendar days.