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 propose that the FDA...

Non-disclosure agreements (NDAs) are agreements in contract law where parties agree that certain information will remain confidential. As such, an NDA binds a person who has signed it and prevents them from discussing any information included in the contract with anyone not authorized by the NDA.

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2023年12月16日 · NDA是一种保密协议，也称为机密协议。 双方在签署协议时同意不泄露协议中的保密信息。 通常用于保护商业机密、技术秘密、专利和其他敏感信息。 2.NDA有哪些类型？ 根据不同的使用情境，NDA有以下几种类型：双向保密协议（Mutual NDA）、单向保密协议（One-way NDA）和多方保密协议（Multi-party NDA）。 其中，双向保密协议适用于两个或多个组织间的机密信息共享；单向保密协议适用于单方向性信息共享；多方保密协议则适用于三个或更多 …

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 pharmaceutical for sale and marketing.

An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate...

2023年2月1日 · 为了保证市场的健康成长，同时⿎励创新和研发，美国食品与药品管理局（Food and Drug Administration, FDA）制定了⼀系列非常完善的监管手段。 在美国，⼀个普通的新化合物从最初的发现到申请上市，大约需要经过15年的时间，其中 FDA 用于审评的时间大约为6到10个月。 美国的联邦食品、药品、化妆品法案 FDCA （Federal Food, Drug and Cosmetic Act）规定了新药审评的过程，此法案有关新药审评最重要的条款相当简单明了。 FDCA 规定，任何⽤于 …

Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval. After an NDA is received, the FDA has 60 days to decide whether to file it so it can be...

Filing a New Drug Application (NDA) is an essential process for pharmaceutical companies aiming to introduce new drugs into various global markets. Each regulatory authority has its own set of guidelines and procedures to ensure the safety, efficacy, and quality of the drug.

2024年10月15日 · Non-disclosure agreements (NDAs) are legally binding agreements to keep information confidential. They go by other names in certain contexts, including confidentiality agreements (CAs), confidential disclosure agreements (CDAs), and proprietary information agreements (PIAs).