Sample Case #4

A. Probably, but the sponsor must request a waiver and submit supporting documentation providing the basis for granting a waiver. The FDA may determine that older children such as adolescents should not be excluded, and only grant a partial waiver.

A. Probably, but the sponsor must request a waiver and submit supporting documentation providing the basis for granting a waiver. The FDA may determine that older children such as adolescents should not be excluded, and only grant a partial waiver.