South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

How many days does the FDA have to respond after an NDA is submitted?

1. 60 days

2. 90 days

3. 180 days

4. 365 days

The correct answer is: 180 days

The correct answer is that the FDA has 180 days to respond after a New Drug Application (NDA) is submitted. This timeframe is established to ensure that the FDA can conduct a thorough review of the submitted data, which includes evaluating the safety and efficacy of the drug, as well as considering the clinical data provided by the manufacturer. This review period is crucial for determining whether the drug should be approved for marketing or if additional information is required before a decision can be made. During this 180-day period, the FDA reviews the application and may conduct meetings or issue queries to the applicant if there are concerns or requests for additional data. This process is designed to balance the need for timely access to new therapies with the imperative to ensure patient safety and proper drug efficacy based on the scientific evidence provided in the NDA. Options suggesting a shorter timeframe, such as 60 or 90 days, do not account for the comprehensive nature of the review process, which is inherently more complex and requires adequate time to ensure all aspects of the application are evaluated properly. The 365-day option exceeds the typical response time for an NDA, as the FDA aims to complete its reviews within a structured timeframe to avoid unnecessary delays in bringing new drugs to market.