This three-minute podcast focuses on ANDA approval standards from a brand company perspective. Brand sponsors continue to submit comments on PSG product-specific guidance and citizen petitions to the FDA requesting heightened approval standards for ANDAs referencing their complex innovator drugs. The great majority of those efforts have been disregarded or denied by the FDA. Yet we have obtained two major revisions to PSGs, revisions that increase the rigor of ANDA approval standards by taking a specific approach to ANDA approval standards advocacy. Our approach starts with recognizing that brand sponsors know more about their drugs than either the FDA or ANDA sponsors. For complex innovator drugs, that knowledge can demonstrate that the FDA's usual approaches to setting ANDA approval standards will lead to standards that are not sufficiently rigorous. In those situations, the brand sponsor can successfully seek heightened ANDA approval standards, but two things are crucial to success. One, it submits only requests that are grantable, that is requests that are specific, certain and supported by compelling evidence. Two, it begins advocacy soon after approval of the complex innovator drug.
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