New Drug Application (NDA) | FDA
The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.
FDALabel - U.S. Food and Drug Administration
For a reference list of established pharmacologic classes (EPCs) and attributes that define a pharmacologic class (i.e., mechanism of action, physiologic effect, chemical structure), click …
FDA Label Search
You can search for labels by drug name and link to the Library’s information resources about marketed drugs. Download All Labels Health information suppliers and others can download …
一文讲透FDA新药注册流程（NDA） - 知乎专栏
2023年2月1日 · FDA根据《政策和程序⼿册》（Manual of Policiesand Procedures，MAPPs）相关规定可采取「优先审查」（Priority Review），评审时间由标准审查的10个月缩短为6个月 …
eCFR :: 21 CFR 314.50 -- Content and format of an NDA.
The NDA is required to contain copies of individual case report forms for each patient who died during a clinical study or who did not complete the study because of an adverse event, …
【干货】Drugs@FDA 专有词汇释义-药品研发-蒲公英 - 制药技术 …
2018年1月10日 · Label标签. FDA批准的标签是对药品的官方描述，包括适应症、适用人群、不良情况（adverse events）（副作用（side effects））、妊娠期用药指导、儿童用药指导、其他 …
浅谈美国药品说明书和标签的管理规定，助力中国本土药品国际化 …
NDA/BLA中，需要提交三种格式的labeling文件：word版、PDF版以及SPL版。 Su老师解释了这三种格式：word文件是提供给审评员以方便修改的；PDF是为了固定word内容以方便查 …
FDALabel: Full-Text Search of Drug Product Labeling | FDA
2024年12月17日 · Web-based application to search labeling documents of FDA-approved drug products. What is Included in Drug Labeling? The FDALabel Database is a web-based …
2019年12月18日 · On March 20, 2019, Novo Nordisk, Inc., submitted for the Agency’s review New Drug Application (NDA) 213182 RYBELSUS (semaglutide) tablets, for oral use. The …
• Conduct early labeling review Receipt to mid-cycle recommendations • Plan for review of labeling Draft Labeling 11 NDA Filing & planning Mid-cycle meeting • Sponsors should submit …