A fatal flaw is any deficiency that renders an ANDA as a whole unreviewable,
including but not limited to an occurrence that requires an ANDA applicant to
manufacture a new demonstration batch of its product; to conduct a new
bioequivalence (BE) study, including BE studies with clinical endpoints; or
significant flaws in the design of a drug product such that the proposed product will
not be able to meet all conditions of use of the reference listed drug.
