Regulatory Affairs Certification (RAC) Practice Exam

What is a key factor a sponsor must demonstrate in a Suitability Petition for an ANDA?

1. Similarity of active ingredients.

2. Bioequivalence to the RLD.

3. Identical labeling to the RLD.

4. Safety and efficacy studies are not needed.

The correct answer is: Bioequivalence to the RLD.

In the context of a Suitability Petition for an Abbreviated New Drug Application (ANDA), the key factor a sponsor must demonstrate is bioequivalence to the reference listed drug (RLD). Bioequivalence refers to the requirement that the generic version of the drug performs in a similar manner to the original branded product, ensuring that it delivers the same therapeutic effect in patients. This aspect is crucial because it ensures that patients receiving the generic version will experience the same clinical outcomes as those receiving the branded drug, ultimately supporting drug efficacy and safety. By demonstrating bioequivalence, the sponsor shows that any differences in formulation between the two versions do not significantly affect the drug's pharmacokinetic properties or overall effectiveness. While similarity of active ingredients, identical labeling, and exemptions from safety and efficacy studies can all be relevant considerations in the broader regulatory context, they are not the primary focus of the Suitability Petition. The most critical aspect for regulatory approval, particularly in terms of patient safety and therapeutic efficacy, lies in proving that the generic formulation performs equivalently to its branded counterpart.