The FDA and Eagle Pharmaceuticals have agreed on the next steps for the development of EA-114, an estrogen receptor antagonist and novel formulation of fulvestrant (Faslodex) used in the treatment of postmenopausal women with breast cancer. The consensus was reached in a...
Halsey, GracePatient Care (Online)
7. Electronic Submission Format 电子提交格式7.1 eCTD Specifications eCTD规范For information on how to incorporate datasets into the eCTD, please reference the Guidance to Industry Providing Regulatory Submissions in Electronic Format: Certain Human Pharmaceutical Product Applications and Related Submissions Usin...
GSK的这款疫苗是基于GMMA（Generalized Modules for Membrane Antigens ）平台来开发的。膜抗原通用模块（...
The main submission, regional administrative folders, and certain subfolders should have specific names. Table 1 shows the organization of modules and their descriptions. 每个项目都有一个指定的模块和子文件夹,应放置属于该项目的文档和数据文件。属于每个 模块的文件要放在相应的文件夹中(例如,m1 至m5 )...
The submission of our NDA brings us one critical step closer to that goal, and we look forward to working closely with the FDA during its review process,” Mr. Serlin concluded. The FDA’s decision on acceptance of BioLineRx’s NDA filing is expected...
1.15.1 Correspondence relating to promotional materials 1.15.1.1 Request for advisory comments on launch materials 1.15.1.2 Request for advisory comments on non-launch materials 1.15.1.3 Presubmission of launch promotional materials for accelerated approval products 1.15.1.4 Presubmission of non-launch pro...
“We remain on track to complete the NDA submission in Q3 2021, provided that we obtain agreement with the FDA on our initial pediatric study plan (iPSP).”Jack Weinstein, CFO and Treasurer of Relief Therapeutics, added: “The outcome of the pre-NDA meeting with the...
October 2015 1.0 Initial Version Updated/Clarified following sections: Section 2.3 (Transitioning to eCTD Format and Resubmission of Non- eCTD Documents), and subsections 2.3.1, 2.3.2, 2.3.3, 2.3.4 Section 2.4 (eCTD Leaf Titles) Section 2.6 (Presubmissions) Section 2.7 (Rolling Submission) Se...
Cross-references to other parts of the report and other parts of the application should be provided with hyperlinks or locations of the modules of an IND, NDA, BLA, or ANDA submission, if applicable. If necessary, consult the FDA regarding the feasibility of submitting certain types of ...