Regulatory Affairs Certification (RAC) Practice Exam

A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to market a:

1. Generic drug with a completely different formulation.

2. New chemical entity when the sponsor has a right of reference to all applicable published studies.

3. Combination product where safety data exists.

4. Drug already marketed in another country.

The correct answer is: New chemical entity when the sponsor has a right of reference to all applicable published studies.

In the context of regulatory submissions, a 505(b)(2) NDA (New Drug Application) is primarily designed to allow for the approval of a new drug where some components of the application rely on data not developed by the applicant but rather on published literature or studies. It provides a pathway for drugs that may share similarities with existing products or existing knowledge. The reason that the second choice—relating to a new chemical entity when the sponsor has a right of reference to all applicable published studies—is not appropriate for a 505(b)(2) NDA is due to the nature of this type of application. In this case, the presence of a new chemical entity signifies that the drug has not been previously reviewed or approved. This means that there isn't a reliance on existing studies or data that would support a 505(b)(2) submission. Instead, a full NDA would be necessary, as the regulatory authorities require comprehensive safety and efficacy data for approval. The other scenarios—like a generic drug with a completely different formulation, a combination product with existing safety data, and a drug already marketed in another country—might offer opportunities to utilize existing research or data to support a 505(b)(2) submission. They can demonstrate that they are seeking approval based