NDA 21-515
Page 4
|
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: _____________________
Date
studies are due (mm/dd/yy):________
If
studies are complete proceed to Section D.
Otherwise, this Pediatric Page is complete and should be entered into
DFS.
|
tion
[Section] D: Completed Studies |
Age/weight
range being partially waived:
Min
_____ kg _____ mo. _____ yr. _____ Tanner
Stage _____
Min
_____ kg _____ mo. _____ yr. _____ Tanner
Stage _____
Comments:
If
there are additional indications, please copy the fields above and complete
pediatric information as directed. If
there are no other indications, 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
(revised 1-18-02)
FOR QUESTIONS ON
COMPLETING THIS FORM CONTACT, PEDIATRIC TEAM, HFD-960
01 [301]-594-7337
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