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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.
Zhang, Huyi; Li, Haitao; Song, Wei; Shen, Diandian; Skanchy, David; Shen, Kun; Lionberger, Robert A; Rosencrance, Susan M; Yu, Lawrence X.
Affiliation
  • Zhang H; Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
AAPS J ; 16(5): 1132-41, 2014 Sep.
Article in En | MEDLINE | ID: mdl-25034968
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Full text: 1 Collection: 01-internacional Health context: 1_ASSA2030 Database: MEDLINE Main subject: United States Food and Drug Administration / Drugs, Generic / Drug Approval / Drug Industry / Fees and Charges Type of study: Guideline / Health_economic_evaluation / Prognostic_studies Country/Region as subject: America do norte Language: En Journal: AAPS J Year: 2014 Document type: Article
Fulltext
Print
XML
PubMed Links
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Full text: 1 Collection: 01-internacional Health context: 1_ASSA2030 Database: MEDLINE Main subject: United States Food and Drug Administration / Drugs, Generic / Drug Approval / Drug Industry / Fees and Charges Type of study: Guideline / Health_economic_evaluation / Prognostic_studies Country/Region as subject: America do norte Language: En Journal: AAPS J Year: 2014 Document type: Article