1. Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017 Subject(s): Drug ApprovalDrug Industry -- standardsDrugs, GenericGuideline AdherenceInvestigational New Drug ApplicationHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Compliance policy for required warning statements on small-packaged cigars Publication: Silver Spring, MD : Center for Tobacco Products, Food and Drug Administration, September 2017 Subject(s): Product Labeling -- standardsProduct Packaging -- standardsTobacco Products -- standardsGuideline AdherenceHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
