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Completeness Assessment of Type II Active Pharmaceutical Ingredient Drug Master Files under Generic Drug User Fee Amendment: Review Metrics and Common Incomplete Items

Crossref DOI link: https://doi.org/10.1208/s12248-014-9630-7

Published Online: 2014-07-18

Published Print: 2014-09

Update policy: https://doi.org/10.1007/springer_crossmark_policy

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