New Drug Application (NDA) | FDA
Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally …
Types of Applications | FDA - U.S. Food and Drug Administration
Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness....
药物审批IND/NDA/BLA流程 - 知乎 - 知乎专栏
IND：新药临床试验申请（Investigational New Drug） NDA： 新药生产上市注册申请 （New Drug Application ） BLA： 生物制品许可申请 （Biologics License Application） ANDA ： 仿制药注 …
Investigational New Drug (IND) Application | FDA
2024年11月18日 · Get to know the investigational new drug application (IND). This includes the types, laws and regulations, and emergency use of INDs.
IND、NDA、 ANDA？一文读懂 - 知乎 - 知乎专栏
NDA（New Drug Application）是指新药经过临床试验后，申报注册上市的阶段；主要目的是确保上市药品安全有效和质量可控，经过NDA，药品获得批准后才能上市销售。
21 CFR Part 312 -- Investigational New Drug Application
(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food …
21 CFR Part 314 -- Applications for FDA Approval to Market a New Drug
Application, new drug application, or NDA is the application described under § 314.50, including all amendments and supplements to the application. An NDA refers to “stand-alone” …
【医药.Plus】一文读懂美国药品注册申请流程（ANDA篇）
2024年2月7日 · 根据《联邦食品、药品和化妆品法》FD&C Act 505，美国药品注册申请分为以下6类，分别是： 新药临床试验申请（Investigational New Drug，简称IND）； 新药上市申 …
New Drug Application - Wikipedia
The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new …
What Is New Drug Application Meaning & Approval Process
New Drug Application is a vehicle through which the drug sponsors formally propose to the FDA for the approval of a new pharmaceutical for sale or market in the US. The data that is …