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How many days are required for FDA drug registration and certification in the United States?
Category：行業(yè)資訊 Date：2024-08-27 16:43:55 Author: Source:
The total time can vary based on the specific circumstances of the application and the FDA's workload.

The number of days required for FDA drug registration and certification in the United States can vary widely depending on the type of drug and the approval pathway:7(2).jpg

  1. New Drug Application (NDA): The review process typically takes 6 to 10 months for standard review and 6 months for priority review.

  2. Abbreviated New Drug Application (ANDA) for generics: The process usually takes 10 to 18 months.

  3. Over-the-Counter (OTC) Drugs: If the drug falls under an existing OTC monograph, the process can be quicker, often a few months.

The total time can vary based on the specific circumstances of the application and the FDA's workload.

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