111. Compounded drug products that are essentially copies of approved drug products under Section 503B of the Federal Food, Drug, and Cosmetic Act Publication: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018 Subject(s): Drug Compounding -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.
112. Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application Publication: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018 Subject(s): Biological ProductsDrug ApprovalDrug PackagingPrescription DrugsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
113. 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.
114. 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.