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Home » GUIDANCE ISSUED ON ANDAs FOR POLYMORPHIC DRUG SUBSTANCES
GUIDANCE ISSUED ON ANDAs FOR POLYMORPHIC DRUG SUBSTANCES
December 17, 2004
Drugmakers submitting abbreviated new drug applications should investigate whether the drug substance under consideration can exist in polymorphic forms — including crystalline and amorphous forms, as well as solvate and hydrate forms — according to a draft guidance released by the FDA.