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. M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use Publication: Silver Spring, MD : Center for Drug Evaluation and Research, October 2017 Subject(s): Documentation -- standardsDrug ApprovalCongresses as TopicEuropean UnionInternational CooperationPharmaceutical Preparations -- standardsHumansCanadaEuropeJapanSwitzerlandUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.