ADVANCES IN THE REVIEW OF GENERIC DRUG APPLICATIONS BY UNITED STATES FOOD AND DRUG ADMINISTRATION, A REGULATORY PERSPECTIVE IN THE ERA OF GDUFA (GENERIC DRUG USER FEE AMENDMENT 2012) Journal title: International Journal of Drug Regulatory Affairs Authors: Maddela Lakshmi Kanth, Insukh Oh Subject(s): Medicine, Internal Medicine, Pharmacology, Pharmacy, Toxicology, Health and Wellness
Completeness Assessment of Type II Active Pharmaceutical Ingredient Drug Master Files under Generic Drug User Fee Amendment: Review Metrics and Common Incomplete Items Journal title: The AAPS Journal Authors: Huyi Zhang, Haitao Li, Wei Song, Diandian Shen, David Skanchy, Kun Shen, Robert A. Lionberger, Susan... Subject(s): Medicine