FDA Final Rule for Children in Clinical Trials

The FDA amended its regulations in order to protect the increasing number of children participating in clinical trials.  The new rule goes into effect today, March 28, 2013, in order to comply with the Children’s Health Act of 2000.

One change aims to clarify the definitions of “guardian” and “permission”.  Another change is that the FDA will “not consider the administration of a placebo to offer a prospect of direct benefit”.  Riskier studies may also require the permission of both parents prior to a child’s enrollment.

Read more at Quorum Blog

Read the entire FDA Rule at the Federal Register