Regulatory Affairs Certification (RAC) Practice Exam

What process should a sponsor use to apply for permission from the FDA for an ANDA that varies from the Reference Listed Drug (RLD) in route of administration, dosage form, or strength?

1. Abbreviated NDA.

2. Suitability Petition.

3. Product Line Extension.

4. New Drug Application.

The correct answer is: Suitability Petition.

The suitability petition is the appropriate process for a sponsor to apply for permission from the FDA for an Abbreviated New Drug Application (ANDA) that differs from the Reference Listed Drug (RLD) in terms of route of administration, dosage form, or strength. This petition allows the sponsor to seek a determination on whether the proposed changes to the drug product meet the necessary criteria for approval, specifically addressing how these variations can still ensure the drug's safety and efficacy. Through a suitability petition, the sponsor provides justification for the differences from the RLD and demonstrates that the new characteristics of the drug do not negatively impact patient safety and performance. This process is crucial for ensuring that generic drugs can be developed in a manner that is both compliant with regulatory standards and responsive to the needs of the market. In contrast, an abbreviated NDA does not apply in this context, as it is generally used for a new chemical entity rather than for variations of an existing drug. A product line extension typically refers to marketing variations of a brand name drug that do not require a separate ANDA or NDA. The new drug application is a broader, more comprehensive application used when a drug is sufficiently different from an existing drug, requiring a full review rather than the more streamlined process afforded to gener