1. Compounding certain beta-lactam products in shortage under Section 503A of the Federal Food, Drug, and Cosmetic Act: immediately in effect guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2022 Subject(s): Anti-Bacterial Agentsbeta-LactamsDrug CompoundingGovernment RegulationLegislation, DrugUnited StatesUnited States. Food and Drug Administration
2. Limited population pathway for antibacterial and antifungal drugs Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, August 2020 Subject(s): Anti-Bacterial AgentsAntifungal AgentsLegislation, DrugUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.