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:
New Drug Application (NDA): The review process typically takes 6 to 10 months for standard review and 6 months for priority review.
Abbreviated New Drug Application (ANDA) for generics: The process usually takes 10 to 18 months.
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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