Regulatory Affairs Certification (RAC) 2025 – 400 Free Practice Questions to Pass the Exam

The process a sponsor should use to apply for permission from the FDA for an Abbreviated New Drug Application (ANDA) that varies from the Reference Listed Drug (RLD) in route of administration, dosage form, or strength is through a suitability petition.

A suitability petition is specifically designed for situations where an applicant seeks to market a generic product that is not identical in formulation to the reference product but instead varies in certain aspects such as dosage form, route of administration, or strength. This petition must demonstrate that the proposed change is suitable and justifies the development of the ANDA. The FDA reviews this petition to determine whether the proposed variations can be approved, paving the way for the applicant to proceed with the ANDA.

The other options do not specifically apply to this situation. An Abbreviated NDA would not be appropriate as it is generally reserved for those applications that do not meet the criteria for an ANDA, such as new chemical entities or significant modifications to a drug. A Product Line Extension is related to marketing strategies rather than regulatory submissions and typically involves changes to existing products where the formulation remains largely consistent. A New Drug Application is required for entirely new drugs that have not yet been approved and is not specific to variations of existing products, which