Regulatory Affairs Certification (RAC) Practice Exam

What does the FDA's Office of Generic Drugs prioritize when reviewing original ANDAs?

1. First-come, first-served basis

2. Fast track applications first

3. Priority for products with high demand

4. Random selection of applications

The correct answer is: First-come, first-served basis

The FDA's Office of Generic Drugs does not prioritize applications on a first-come, first-served basis. During the review of original Abbreviated New Drug Applications (ANDAs), the agency focuses on several critical factors, including the potential market impact of the generic product and the therapeutic equivalence to the reference listed drug. The correct focus of the Office of Generic Drugs is on products with high demand. This prioritization ensures that generic medications that can address significant patient needs or shortages in the market are expedited in the approval process. By prioritizing these types of products, the FDA aims to improve access to affordable medications, especially for those that treat chronic or critical conditions where alternatives may be limited. This approach effectively addresses healthcare needs by facilitating faster market entry for generics that can significantly benefit patients and the healthcare system overall. While other factors such as fast track applications exist, they are not the primary focus of the Office of Generic Drugs when it comes to the review of original ANDAs.