Briefing packages can be due within days of receiving meeting granted notification, so make sure you are well on your way before sending a meeting request letter. Meetings are data driven so make sure data to be in...
[2] KemPharm, Inc. Completes Pre-IND Meeting with FDA for NME Prodrug of Hydromorphone, KP511....
The meeting package should provide summary information relevant to the product and anysupplementary information needed to develop responses to issues raised by the requester or review division. It is critical that the entire meeting package content suppo...
a novel class of immunotherapies. SSIs are designed to stimulate an innate immune response in targeted organs or tissues to reverse the chronic inflammation underlying many conditions including cancer, inflammatory bowel disease, inflammatory lung disease and arthritis...
“The successful completion of the pre-IND meeting process with the FDA for KP1077 affirms our plan to submit the IND application by mid-year 2022 and, following that, potentially initiate a Phase 2 trial of KP1077 in IH as early as the third quarter of 2022,” stated Travis Mickle, Ph...
◆第30天提供preIND package(所有问题的背景信息、包括所有附件不超过150页); ◆第60天收到书面回复或电话会议,电话会议将在结束1个月左右收到Meeting Minute; ◆一个产品或多个高度相似的产品只有1次pre-IND的机会,需要进一步沟通的问题可以要求Type D会议,但是Type D只有30%~50%的批准概率; ...
◆第30天提供preIND package(所有问题的背景信息、包括所有附件不超过150页); ◆第60天收到书面回复或电话会议,电话会议将在结束1个月左右收到Meeting Minute; ◆一个产品或多个高度相似的产品只有1次pre-IND的机会,需要进一步沟通的问题可以要求Type D会议,但是Type D只有30%~50%的批准概率; ...
您是否已准备好向FDA提供一个全面的简报包(briefing package/PIND package)? 简报包可以在收到会议批准通知的几天内完成,所以在发送会议请求信之前,请确保您已经做好了准备。 会议是由数据驱动的,所以要确保简报包中包含的数据是可用的...