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Washington Drug Letter
Oct. 15, 2012 | Vol. 44 No. 41
ANDAs Lacking QbD Elements Will Sit In 180-Day Review: MAPP
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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