Quote from Wikipedia: "Generic drug applications are termed "abbreviated" because (in comparison with a New Drug Application) they are generally not required to include preclinical (animal and in vitro) and clinical (human) trial data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy volunteers."
Whoever claims a phase 3 study would need to be redone is talking BS!
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