Background: Welcome to the Food and Drug Administration, Center for Drug Evaluation and Research’s educational activity entitled, “The Past, Present, and Future of FDA Human Drug Regulation.” The overall goal of this activity is to give health professionals, regulated industry, consumers, and other participants a clear understanding of the changed world of FDA human drug regulation. Learning the historical basis of FDA drug regulation will help participants appreciate that laws of the United States Congress govern FDA’s work. Being aware of new systems will enable the target audience to understand the complexities of CDER’s regulatory work in an era of transparency and the public health responsibility the Center faces while completing its mission.
Credits: The Food and Drug Administration, Center for Drug Evaluation and Research is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Food and Drug Administration, Center for Drug Evaluation and Research designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity. Credit for this activity will no longer be available after 11/30/2013.
Learning Objectives: Upon completion of this activity, the participant will be able to:
- Describe and explain the drug development and review process in the United States
- Outline CDER’s role in post-marketing safety surveillance for medical products
- Identify ways CDER disseminates safety information about medical products to both healthcare professionals and their patients
- Identify methods used by CDER to protect public health