Final answer:
The term associated with the FDA's review of a generic drug based on oral bioavailability studies is an Abbreviated New Drug Application (ANDA), which demonstrates that the generic drug is therapeutically equivalent to its brand name counterpart.
Step-by-step explanation:
When the Food and Drug Administration (FDA) reviews a generic drug for marketing based on a study comparing the oral bioavailability of the generic to the brand name product, the term associated with this review is Abbreviated New Drug Application (ANDA). The ANDA is a streamlined process that allows a generic drug to be approved for marketing without the same level of clinical testing that is required for the approval of a new brand name drug.
Generic drugs are required to be therapeutically equivalent to their brand-name counterparts, meaning they must deliver the same amount of active ingredient into a patient's bloodstream in the same amount of time. This equivalency ensures that the generic will perform the same as the branded drug in terms of safety, efficacy, and intended use. Generic drugs are significant in the healthcare industry because they offer a less expensive alternative to brand-name drugs, making medication more accessible to patients.
As of 2012, approximately 80% of all FDA-approved drugs were available in generic form, highlighting the importance of the ANDA process in the pharmaceutical market. However, the approval process can still be rigorous as the FDA ensures the safety and efficacy of generic medications for consumers.