1. Health document submission requirements for tobacco products: (revised) Publication: Silver Spring, MD : Center for Tobacco Products, October 2017 Subject(s): Documentation -- standardsTobacco Products -- standardsDrug ApprovalHealthTerminology as TopicTobacco Products -- adverse effectsTobacco Products -- toxicityHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.
2. Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff Publication: [Silver Spring, Maryland] : Center for Devices and Radiological Health, September 29, 2017 Subject(s): Device Approval -- standardsDocumentation -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.