Does the ANDA process require manufacturers to do extensive clinical research?
Abstract:No. The FDA's Abbreviated New Drug Application or ANDA process, used by generic manufacturers to apply for approval for their copies of drugs, does not require the company to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness.
Instead, generic manufacturers need to show that their product is bioequivalent or performs in the same manner as the original, innovator drug.
Bioequivalence can be demonstrated by measuring the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers.
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