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    Drugs and Devices for Unique Situations: Humanitarian, Compassionate and Emergency Use

    Arent Fox partner Wayne Matelski will be speaking at NACUA’s November CLE program on the topic of Drugs and Devices for Unique Situations: Humanitarian, Compassionate and Emergency Use at the Omni Shoreham Hotel in Washington, DC on November 13, 2008 from 1:30 pm–2:45 pm. 

    This program will focus on:

    • Overview of regulatory requirements
    • Clarifying confusion between compassionate and emergency use
    • Informed consent requirements
    • Obligations of physician, IRB, institution, FDA and drug/device company; and
    • Applicability of sponsored research agreements to these unique situations