- Activity Description, and Learning Objectives
- System Requirements
- Replacement of CE Statement of Credit
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.
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
- Operating System: Windows 2000 or higher
- Broadband Internet Access: Internet Explorer 6.0 or 7.0; Firefox 2.0 or 3.0; Netscape 8.0 or 9.0; Macromedia Flash Player 9 or 10
- Hardware: Intel Pentium II at 233 MHz or greater; 128 MB RAM; targeted screen resolution of 1028x768
- Courseware: Compliant with Section 508 Standards. Users who use assistive technologies such as screen readers will require a sound card plus speakers or headphones.
The faculty and planning committee are FDA/CDER staff who, as employees, have claimed no interests, financial or otherwise, with commercial supporters, manufacturers, or providers of products that may be presented in this activity.