11. Safety and performance based pathway: guidance for industry and Food and Drug Administration Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, September 20, 2019 Subject(s): Drug ApprovalTherapeutic EquivalencySafetyHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
12. Determining whether to submit an ANDA or a 505(b)(2) application Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2019 Subject(s): Drug ApprovalDrugs, InvestigationalInvestigational New Drug ApplicationDrug LabelingTherapeutic EquivalencyHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.
13. The Special 510(k) Program: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 13, 2019 Subject(s): Device Approval -- standardsTherapeutic EquivalencyHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
