1. 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.
2. Instructions for use: patient labeling for human prescription drug and biological products : content and format Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022 Subject(s): Biological ProductsGovernment RegulationPrescription DrugsProduct LabelingUnited StatesUnited States. Food and Drug Administration
3. Direct-to-consumer prescription drug advertisements: presentation of the major statement in a clear, conspicuous, and neutral manner in advertisements in television and radio format final rule : questions and answers : guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023 Subject(s): Direct-to-Consumer Advertising -- legislation & jurisprudenceDrug IndustryGovernment RegulationLegislation, DrugPrescription DrugsUnited States
