1. FY 2018 medical device user fee small business qualification and certification: guidance for industry, Food and Drug Administration staff and foreign governments Publication: Silver Spring, MD : Center for Devices and Radiological Health, August 29, 2017 Subject(s): Device ApprovalSmall BusinessEligibility DeterminationTaxesHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Prescription Drug User Fee Act waivers, reductions, and refunds for drug and biological products Publication: Silver Spring, MD : Center for Drug Evaluation and Research, October 2019 Subject(s): Drug Approval -- economicsDrug Approval -- legislation & jurisprudenceInvestigational New Drug Application -- legislation & jurisprudenceDiffusion of InnovationEconomics, PharmaceuticalOrphan Drug Production -- economicsPublic HealthSmall BusinessHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.
