1. Food Safety: a national strategy is needed to address fragmentation in federal oversight : report to Congressional requesters Publication: Washington, D.C. : U.S. Government Accountability Office, January 2017 Subject(s): Food SafetyFood SupplyGovernment RegulationInterinstitutional RelationsFederal GovernmentPublic HealthHumansUnited StatesUnited States. Department of Agriculture.United States. Food and Drug Administration.
2. Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy Publication: Silver Spring, MD : Center for Drug Evaluation and Research, February 2017 Subject(s): Emergency Medical Services -- legislation & jurisprudenceEmergency Responders -- legislation & jurisprudencePharmaceutical Preparations -- supply & distributionDrug TherapyLegislation, DrugHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.
3. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2017 Subject(s): Automatic Data Processing -- standardsInvestigational New Drug ApplicationDrug Approval -- legislation & jurisprudenceDrug Approval -- organization & administrationHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.
4. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders Publication: Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, January 2017 Subject(s): Civil Defense -- legislation & jurisprudenceDevice ApprovalDrug ApprovalEmergenciesTerrorismEmergency Medical ServicesEquipment SafetyOff-Label UsePublic HealthSafetyHumansUnited StatesUnited States. Department of Health and Human Services.United States. Department of Homeland Security.United States. Food and Drug Administration.
5. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff Publication: Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, June 2017 Subject(s): Device ApprovalDrug ApprovalInvestigational New Drug ApplicationAccess to InformationClinical Trials as TopicDrugs, InvestigationalHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
6. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3) Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2017 Subject(s): Arrhythmias, Cardiac -- chemically inducedArrhythmias, Cardiac -- diagnosisCardiac Electrophysiology -- methodsCardiac Electrophysiology -- standardsDrug ApprovalElectrocardiography -- standardsLong QT Syndrome -- chemically inducedCardiotoxinsClinical Trials as TopicCongresses as TopicDiagnosis, Computer-AssistedDrug-Related Side Effects and Adverse ReactionsInternational CooperationPharmaceutical Preparations -- administration & dosageReference StandardsResearch DesignSex FactorsHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
7. Q3C--tables and list Publication: Silver Spring, MD : Center for Drug Evaluation and Research, [June 2017] Subject(s): Chemistry, Pharmaceutical -- standardsDrug Compounding -- standardsSolvents -- classificationCongresses as TopicInternational CooperationSolvents -- adverse effectsHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
8. IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017 Subject(s): Clinical Trials as Topic -- standardsHuman Experimentation -- standardsInformed Consent -- standardsEthics Committees, ResearchEthics, ResearchInformed Consent -- ethicsResearch SubjectsRiskHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
9. M4E(R2): the CTD--efficacy Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017 Subject(s): Drug ApprovalInvestigational New Drug ApplicationDrugs, InvestigationalClinical Trials as TopicCongresses as TopicInternational CooperationHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
10. Consumer antiseptic wash final rule: questions and answers : (Small Entity Compliance Guide) Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017 Subject(s): Anti-Infective Agents, LocalConsumer Product SafetyHand SanitizersNonprescription DrugsAnti-Bacterial AgentsAnti-Infective Agents, Local -- adverse effectsSoapsTriclosanHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.