Transcription of Compton, Kimberly - Food and Drug Administration
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Compton, Kimberly - Food and Drug Administration
Page1of4 Compton, KimberlyFrom: Compton, KimberlySen t:Friday,April17,20097:39 PMTo:' 'Cc: Compton, KimberlySubject:RE:NDA22-266 - ONSOLISREMSR eviewTeleconferencesAttachments:N ,Attachedpleasefinda , ,willthesebesentin MSWordtrackedchangestothedocumentsprovid edin NDAS equence0033?Regardingthepediatricdevelop mentplan,priorto ourteleconferencenextWednesday,I hopetobeabletoprovidea briefresponsetoeachofyour3 niceweekend!Bestregards,DaveDavidT ,afterweironoutthosecoupleofpointsyoumen tion, cleancopyofthelabeland(hopefully) , ,I willbesendingyou(Ibelievetheywillbeready tomorrow)additionalcommentsontheREMS materials(mostlytheeducationscomponents, etc) goodtopictodiscussintheTCis howtheorderof! ,weareworkingontheotheraspectsoftherevie wthatwillpreparetheapplicationforapprova lifwereachagreementonallthepiecesandthat includesthepediatricplan/materials, , , ,thePREA requirementsarethatyoucarryouta study(ies)toassessthepharmacokinetics,sa fety,andefficacyin ,asagreeduponbetweentheDivisionandtheSpo nsormustbepresentedtothePediatricResearc handReviewCommittee(bytheDivision) commitmenttostudythepharmacokinetics,eff icacyandsafetyofONSOLISinb(4,thepediatri cpopulationolderthan.)
Page 3 of4 We therefore request you submit the following by as soon as possible: 1. A commitment to studythe pharmacokinetics, efficacy and safety ofONSOLIS in b(4, the pediatric population older than .(You do notneed to submit
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