IND number号不是美国FDA申报注册号哦。IND是Investigational New Drug的缩写,指的是新药临床研究审核,是新药研发上市的一个环节,并不是申报注册号。美国FDA的申报注册号通常指的是NDA(New Drug Application)或者ANDA(Abbreviated New Drug Application)的编号,分别对应新药和仿制药的上市申请注册。所以说,IND number号...
在初始IND申请提交前,为解决临床试验过程中出现的问题,尤其是当申请人遇到的有关研发产品问题而FDA提供的指南和其他信息不能完全解答时;FDA与申请人可以召开Pre-IND会议。在资源许可范围内,FDA鼓励召开有助于药品审评以及解决药品相关...
IND Submission means the submission by the Company of its first IND for G-202 as confirmed by the assignment of an IND number by the FDA. Sample 1Sample 2 Based on 2 documents SaveCopy IND Submission means the collection, assembly and presentation of an Investigational New Drug application, ...
Artelo Biosciences, Inc. recently announced it has completed a pre-IND meeting with the US FDA regarding the manufacturing, preclinical, and clinical development plan for ART26.12. Based on the FDA’s feedback, the company also announced it plans to file an IND application for the use of ART...
less controlled conditions in clinical practice in contrast to clinical trials, longer durations of nonclinical testing can be valuable. The durations of repeated-dose toxicity studies to support marketing for different treatment durations are outlined in Table 2. However, for a small number of ...
To reduce the number of animal sacrifices at each timepoint, it may be appropriate to provide interim arthroscopic assessments and/or MRI evaluations in the animal studies. At the time of each sacrifice, the mechanical integrity of the cartilage should be assessed along with gross examination. ...
Additionally, as part of the communication with FDA, it agreed that additional non-clinical studies are not required prior to initiation of the DehydraTECH-CBD IND program, given the compelling data already presented by Lexaria and others regarding the safety and ...
与药理学和毒理学信息相关的FDA指导性文件可以在官网获得,并描述了可以满足非临床毒理学研究有关的要求的方法。除了描述每项研究的结果外,IND申请人被要求还需要包括评估每项研究结果并得出结论的负责人的身份和职位等信息,且此负责人认...
FDA Guidance documents relevant to Pharmacology and Toxicology information are available and describe ways in which requirements related to conduct of non-clinical toxicology studies may be met. In addition to description of the results of each study, the IND sponsor is required to include the identi...
All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document, contact (CDER) Meredith Chuk at 301-796-2340 or (CBER) the Office of Communication, Outreach, and Development at 800...