TY - CHAP M1 - Book, Section TI - Regulatory Affairs and Pharmaceutical Industry A1 - Dill, Jennifer L. A1 - A. Kapp, Daniel A2 - Malone, Patrick M. A2 - Witt, Benjamin A. A2 - Malone, Meghan J. A2 - Peterson, David M. PY - 2022 T2 - Drug Information: A Guide for Pharmacists, 7e AB - Learning ObjectivesAfter completing this chapter, the reader will be able to:Compare and contrast the missions of the Department of Health and Human Services (DHHS), the Food and Drug Administration (FDA), and Center for Drug Evaluation and Research (CDER).Describe the methods the FDA uses to communicate important safety information.Describe the role of the CDER Division of Drug Information (DDI).List the main services provided by the CDER DDI.Categorize the different clinical and regulatory resources provided by the FDA.Identify the FDA and DDI resources for small business and the pharmaceutical industry.Discuss student and professional opportunities within the FDA and the pharmaceutical industry.Describe how health care professionals (HCPs) are regulated in the pharmaceutical industry.Determine acceptable interactions between pharmaceutical companies and practitioners.Explain the importance of collecting adverse event and product complaint information. SN - PB - McGraw Hill CY - New York, NY Y2 - 2024/03/29 UR - accesspharmacy.mhmedical.com/content.aspx?aid=1190462143 ER -