Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applants must scientifically demonstrate that the product is bioequivalent (i.e., performs in the same manner as the innovator drug).
During review, all applications are evaluated for chemistry, manufacturing and controls and labeling. In addition, bioequivalence and microbiology are evaluated as necessary or as appropriate.
The chemistry, manufacturing and control (CMC) review process begins with the review of a drug master file (DMF). The DMF is reviewed only when referenced in an application. OGD mostly reviews DMFs for drug substances. The bulk of OGD reviewers work on things other than ANDAs.