NDA
21-515
Page
2
q
Other _________________________
If studies are deferred,
proceed to Section C. If studies are
completed, proceed to Section D.
Otherwise, this Pediatric Page is complete and should be entered into
DFS.
|
Section
C: Deferred Studies |
Age/weight range being partially waived:
Min
_____ kg _____ mo. _____ yr. _____ Tanner
Stage _____
Min
_____ kg _____ mo. _____ yr. _____ Tanner
Stage _____
Reason(s)
for partial waiver:
q Products in this class for this
indication have been studied/labeled for pediatric population
q Disease/condition does not
exist in children
q Too few children with
disease to study
q There are safety concerns
q Adult studies ready for
approval
q
Other: Pediatric Rule currently in litigation_________
If there are additional
indications, please proceed to Attachment A.
Otherwise, this Pediatric Page is complete and should be entered into
DFS.
This page was completed
by:
{See appended
electronic signature page}
_____________________________
Regulatory Project
Manager
cc: NDA
HFD-950/Terrie Crescenzi
HFD-960/Grace Carmouze
(revised 9/24/02)
FOR QUESTIONS ON
COMPLETING THIS FORM CONTACT, PEDIATRIC TEAM, HFD-960
301-594-7337
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