1. ANDA submissions--amendments to abbreviated new drug applications under GDUFA Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018 Subject(s): Drugs, Generic -- standardsInvestigational New Drug ApplicationDrug ApprovalHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Acne vulgaris: establishing effectiveness of drugs intended for treatment Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018 Subject(s): Acne Vulgaris -- drug therapyDrug Evaluation -- standardsClinical Trials as Topic -- standardsEndpoint DeterminationResearch Design -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
3. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017 Subject(s): Clinical Laboratory TechniquesDevice Approval -- standardsDiagnostic Test Approval -- standardsIn Vitro Techniques -- standardsReagent Kits, Diagnostic -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
4. 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.
5. Allergic rhinitis: developing drug products for treatment Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2018 Subject(s): Clinical Trials as TopicDrug EvaluationRhinitis, Allergic -- drug therapyAdrenal Cortex Hormones -- therapeutic useAdultChildDrug CombinationsResearch DesignSingle-Blind MethodHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
6. Anthrax: developing drugs for prophylaxis of inhalational anthrax Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018 Subject(s): Anthrax -- drug therapyAnthrax -- prevention & controlAntibiotic ProphylaxisClinical Trials as TopicDrug Evaluation, Preclinical -- standardsDrugs, Investigational -- therapeutic useInhalation ExposureAdultChildEndpoint DeterminationMicrobial Sensitivity Tests -- standardsPediatricsProduct Surveillance, Postmarketing -- standardsResearch DesignHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
7. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2017 Subject(s): Anti-Bacterial Agents -- therapeutic useBacterial Infections -- drug therapyDrug ApprovalDrug Resistance, BacterialInvestigational New Drug ApplicationClinical Trials as TopicHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
8. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018 Subject(s): Clinical Trials as TopicConsensusDevice ApprovalEquipment and Supplies -- standardsVoluntary ProgramsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.
9. Assessing user fees under the Prescription Drug User Fee Amendments of 2017 Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018 Subject(s): Fees and ChargesInvestigational New Drug Application -- economicsPrescription Drugs -- economicsBiological Products -- economicsOrphan Drug Production -- economicsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
10. Assessing user fees under the biosimilar user fee amendments of 2017 Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018 Subject(s): Biosimilar Pharmaceuticals -- economicsFees and ChargesInvestigational New Drug Application -- economicsDrug Evaluation -- economicsParenteral Nutrition Solutions -- economicsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.