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