Which of the following changes to an approved NDA can be implemented prior to FDA approval?

The correct answer is based on the regulatory framework established by the FDA. In the context of approved New Drug Applications (NDAs), changes that can be implemented prior to FDA approval typically pertain to those that do not affect the product's safety or efficacy profile nor require extensive submission processes.

In this case, extending the expiration date based on stability data that is already obtained from the approved application is permissible. This is because such a change is strictly a reflection of data already contained in the NDA and does not alter the formulation, dosing, or drug characteristics that may require additional review or approval. The stability studies conducted to support a longer shelf life would have already been reviewed during the original NDA review process, and as long as the data supports the new expiration without any changes to the product or its safety, this extension can proceed.

On the other hand, changes such as a formulation alteration, marketing budget increase, or packaging type adjustment generally require FDA oversight or approval because they may have implications for the drug's performance, safety, efficacy, or labeling. Formulation changes can affect the pharmacokinetics and pharmacodynamics of the drug, while packaging changes might impact how the drug is stored, handled, or delivered. Similarly, changes in marketing strategies do not