New Drug Application

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New Drug Application

Also known as: NDA

Learn about this topic in these articles:

major reference

In pharmaceutical industry: The New Drug Application
The second important regulatory document required by the FDA is the New Drug Application (NDA). The NDA contains all of the information and data that the FDA requires for market approval of a drug. Depending on the intended use of the drug…
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drug regulation

In therapeutics: Indications for use
…clinical trials are successful, a new drug application (NDA) must be approved before it can be licensed and sold. This process usually takes years, but if the drug provides benefit to patients with life-threatening illnesses when existing treatments do not, then accelerated approval is possible. Physicians can receive permission to…
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