1. Facility definition under Section 503B of the Federal Food, Drug, and Cosmetic Act Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018 Subject(s): Drug Compounding -- standardsDrug Industry -- standardsContract ServicesHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.
2. 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.
3. Advancement of emerging technology applications for pharmaceutical innovation and modernization Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017 Subject(s): Biomedical Technology -- standardsDrug Industry -- standardsInventionsQuality Assurance, Health CareQuality ImprovementHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
