INTERACT是指在产品开发早期特定时间举行的会议。召开INTERACT会议合适的时间通常是申请人已确定将在临床研究中评估研究性产品,并且该研究性产品已进行了一些初步的临床前概念验证(proof-of-concept,POC)研究,但尚未设计和进行最终的毒理学研究。 ...
2024年9月20日，FDA批准了AstraZeneca 开发的FluMist无针鼻腔喷雾剂，用于预防2至49岁人群中由A型和B型流感病毒引起的流感疾病。这是首款可供符合条件的患者自行接种或由照护者接种的流感疫苗，通过鼻腔喷入。该疫苗最初于2003年获得FDA批准，适用于5至49岁人群；2007年，FDA批准将其使用范围扩大至2至5岁儿童。S...
“The INTERACT meeting we conducted with the FDA is an important first step in our development of AP-Skin-01. We considered the meeting to be very successful, with productive feedback from the FDA reviewers and stro...
HPC Intelligence│FDA法规培训:CMC研发与准备试点计划(CDRP) Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement 2024年9月26日,FDA在肿瘤药物咨询委员会(ODAC)审评会议上讨论了免疫检查点抑制剂(ICIs)联合化疗一线治疗不同 PD-L1 蛋白表达水平的两种癌症患者的风险获益评估。 会议上,FDA对PD-1...
FDA early interaction, such as INTERACT and Pre-IND meeting preparation and engagement Assessment of eligibility for FDA expedited programs and Orphan Drug Designation (ODD) Design nonclinical development plan Development of CMC strategy including raw material sourcing and initial process development ...
美国FDA 指导原则 用于修复或替换膝关节软骨的产品的IDE和IND的工业制备指南 英文原版.pdf,Guidance for Industry Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage Additional copies of this guidance are available from the O
Guidance outlining clear recommendations for sponsors and for FDA staff and managers as well for Pre-Submission meetings as expected timeframes for scheduling meetings Mechanics of requesting any FDA meeting and what you need to know to be successful with co...
It also appears to have continued to shift the focus away from degree of CMC-readiness, although our experience tells us that this continues to be a consideration in CBER’s review of INTERACT meeting requests. The draft guidance also describes pre-BLA meeting considerations, noting that FDA “...
The January 2025 draft guidance recommends that, shortly after the End of Phase 2 meeting, there should be agreement between FDA and the sponsor on the design of the confirmatory trial. In practice, this seems ambitious, if not outright impractical, for situations where a novel surrogate or int...
The FDA can help in the development of novel innovative products, and seeking early guidance, particularly when working with cell and gene therapy products, is invaluable when navigating complex or challenging preliminary product development strategies. An INTERACT meeting can provide crucial insight on ...