Pediatric Drug Development Solutions 2000
3) FDA should adopt the principles described in Subpart D-Additional Protections for Children Involved as Subjects in Research (45 CFR Subtitle A: 46.401-46.409). This recommendation has been endorsed by the American Academy of Pediatrics and PhRMA. Note: The Pediatric Ethics Working Group agreed that it is appropriate for FDA to consider adoption of a similar statement. A committee has been established to address this issue.