1. Definitions of suspect product and illegitimate product for verification obligations under the Drug Supply Chain Security Act: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2023 Subject(s): Drug IndustryLegislation, DrugDrug PackagingDrug and Narcotic ControlGovernment RegulationUnited States
2. Enhanced drug distribution security at the package level under the Drug Supply Chain Security Act: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023 Subject(s): Drug IndustryDrug and Narcotic ControlDrug PackagingGovernment RegulationSecurity MeasuresUnited StatesUnited States.United States.
3. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023 Subject(s): Biological ProductsClinical Trials as TopicData AnalysisDecision MakingDrug ApprovalDrug IndustryDrug and Narcotic ControlGovernment RegulationUnited StatesUnited States.
4. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies : guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023 Subject(s): Counterfeit DrugsDrug IndustryDrug and Narcotic ControlFraudGovernment RegulationSubstandard DrugsUnited StatesUnited States.
