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ANDAs Short on QbD Should Sit in 180-Day Review Queue, New OGD MAPP States

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ANDAs that lack basic quality-by-design (QbD) elements will be categorized as requiring “major” amendments and more extensive FDA consideration, according to a new Manual of Policies and Procedures (MAPP) for reviewers in CDER’s Office of Generic Drugs (OGD).

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