安全性更新报告:NDA申报者需要向FDA呈报的有关药物安全性的最新报告,包括可能影响药物使用前景的新资料,或草拟的药物说明中桔抗性、警告、慎用和副作用的资料。在NDA 4个月之后,以及申报者已经得到FDA批准函之后,或者在FDA认为必要的任何时候,安全性更新报告就成为必要的。 增补资料:已批准NDA产品的某些改变,需做销售...
美国FDA 指导原则 药品主文件行业指南 英文原版.pdf,Drug Master Files Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted wit
It should be noted that the submission of an ADRG does not eliminate the requirement to submit a complete and informative define.xml file corresponding to the analysis datasets.建议将编制分析数据审查员指南 (ADRG) 作为临床试验符合标准的分析数据提交的重要组成部分。ADRG为FDA审查员提供了分析数据集和...
Reports the rejection of the New Drug Application of Merck Santé by the U.S. Food and Drug Administration. Absence of data on the efficacy of acamprosate; Need for additional clinical trials.EBSCO_bspManufacturing Chemist
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 used in the treatment of postmenopausal women with breast cancer.
Rolling submission of a new drug application (NDA) to the FDA has been initiated for the investigational MEK inhibitor mirdametinib (formerly PD-0325901) in pediatric and adult patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), according to a press release from Spri...
在药物研发早期阶段与FDA讨论在研药物的研发计划和数据,能够及时发现和解决研发中出现的问题,有助于加快药物后续研发和批准上市。此外,新药研发公司可以在提交上市申请(NDA/BLA)时向FDA滚动递交(rolling submission)新药研究资料。这些优惠政策都为加快新药的研发提供有利保障。
application to submit to the FDA," said Uma Sharma, Ph.D., Chief Executive Officer of MMS. “Working as a strategic development partner on this submission has been a phenomenally rewarding experience in uncharted waters. We are grateful to MAPS PBC for entrusting MMS to be a p...
The FDA has filed an acceptance and priority review for a new drug application (NDA) for vorasidenib for the treatment of patients with IDH-mutant diffuse glioma. A Prescription Drug User Fee Act (PDUFA) action date of August 20, 2024, has been set.1 Findings from the pivotal phase 3 I...
Executive Vice-President of Research & Development and Chief Scientific Officer at Servier."The submission of global regulatory filings for vorasidenib serve as validation of Servier's global oncology commitment while marking a possibly significant milestone for...