How many days does the FDA have to file, or refuse to file, an NDA after receipt?

The Food and Drug Administration (FDA) is required to review a New Drug Application (NDA) within a specified timeframe to ensure that the development of new drugs is efficient and compliance with regulatory standards is upheld. Upon receiving an NDA, the FDA has 60 days to determine whether to accept the application for review or refuse to file it.

During this 60-day period, the FDA assesses whether the application is sufficiently complete for the substantive review process. If the application is found to be lacking critical data or if there are other significant issues, the FDA will refuse to file the application, which halts the process until the applicant addresses the deficiencies. This timeline ensures that drugs do not unnecessarily occupy FDA resources if they do not meet initial regulatory standards, allowing for a focus on applications that are likely to meet the criteria for safety and efficacy.