- 3.申请人在会议召开前30天,必须提交一份会议简报文件,其中包括最终确定的问题和支持FDA对问题的回复的支持信息。 Reference: 21 Code of Federal Regulations-Part 312.47 Meetings Formal Meetings Between the FDA and Sponsors or Ap...
1)Pre-Submission Meeting – a meeting in which an applicant has an opportunity to discuss and explain the format and content of an ANDA to be submitted. Note: Although the proposed content of the ANDA will be discussed, pre-submission meetings...
The FDA’s responses and guidance have been aligned with the company’s clinical, CMC, and preclinical development plans and solidifies Lantern’s timeline for an IND submission and clinical trial initiation in Q2 2023. The upcoming LP-184 ...
(Note: This article focuses on drug development as an example, but a similar process, called a pre-submission program, is applicable to development of a device.) PRE-IND MEETING Sponsors looking for pre-IND guidance must request a Type B meeting with the FDA, which can be an opportunity ...
FDA认为Pre-IND会议的益处: ●识别和避免不必要的研究 ●确保设计必要的研究以提供有用的信息 ●获得FDA对拟议研究策略的支持 ●最大限度地减少临床试验暂停(clinical hold)的可能性 ●为创造性地交流意见提供机会 ●获得监管方面的...