Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -261

Accepted - Volume 3

Comment Record
Commentor Ms. Cecile Childrose Date/Time 2002-11-14 09:33:30
Organization Reed Group, Ltd.
Category Health Professional

Comments for FDA General
Questions
1. General Comments This type of testing should only be conducted on individuals who have reached the age of consent and who have chosen to take part in this type of testing. Further, this should only occur after thorough education has been provided regarding the potential risks to the subjects who volunteer, and others who care about them.




EC -261