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U.S. Department of Health and Human Services

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  • CDERLearn
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    The Past, Present, and Future of FDA Human Drug Regulation

      

    About This Site: The FDA has contracted development and management of this educational activity. FDA’s privacy policy applies while you are on this site.
    Registration: You can participate in this training without taking the post test.  However, registration information is required to enter this course and use the bookmarking feature.  To receive continuing education credit and/or certificate, you must take a post test and complete an evaluation.

    - Activity Description, and Learning Objectives

    - Accreditation

    - Disclosure

    - CE Statements of Credit/Certificate of Completion (non-CE)

    - Biography

    - Activity Time

    - Replacement of CE Statement of Credit/Certificate of Completion (non-CE)

    - Free Registration

    - Privacy Policy

     

     

    Start the Activity Exit Disclaimer

    Activity Description 

    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.

    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

    Systems Requirements 

    • 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.

    To Receive Credit for the Activity 

    Participants wishing to receive documented credit for taking the Web-based Activity must:

    • Take the Post Test
    • Complete the Evaluation

     

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