1. 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.
2. 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.
3. 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.
