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Under the reauthorization of GDUFA in 2022 (GDUFA III), the FDA made a commitment to assist industry in the submission of abbreviated new drug applications (ANDA) for complex drug products, defined as those with a complex active ingredient, route of delivery, dosage form or formulation, drug-device combination and/or products for which the choice of an approval pathway would benefit from early scientific engagement (MAPP 5240.10)

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