Welcome to Scribd, the world's digital library. Read, publish, and share books and documents. See more
Download
Standard view
Full view
of .
Save to My Library
Look up keyword
Like this
2Activity
0 of .
Results for:
No results containing your search query
P. 1
guidance

guidance

Ratings: (0)|Views: 1,731|Likes:
Published by FDA Lawyers Blog

More info:

Published by: FDA Lawyers Blog on Apr 15, 2011
Copyright:Attribution Non-commercial

Availability:

Read on Scribd mobile: iPhone, iPad and Android.
download as PDF, TXT or read online from Scribd
See more
See less

04/15/2011

pdf

text

original

 
GuidanceforIndustry
SafetyLabelingChangesImplementationofSection505(0)(4)ofthe
FederalFood,Drug,and
CosmeticAct
DRAFTGUIDANCE
Thisguidancedocumentisbeingdistributedforcommentpurposesonly.
Commentsandsuggestionsregardingthisdraftdocumentshouldbesubmittedwithin90daysofpublicationinthe
FederalRegister
ofthenoticeannouncingtheavailabilityofthedraftguidance.SubmitcommentstotheDivisionofDocketsManagement(HFA-305),FoodandDrugAdministration,5630FishersLane,nn.1061,Rockville,MD20852.Allcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishesinthe
FederalRegister.
Forquestionsregardingthisdraftdocument,contact(CDER)KristenEverettat301-796-5400,or(CBER)theOfficeofCommunication,Outreach,andDevelopment(OCOD)at301-827-1800or800-835-4709.
U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)April2011DrugSafety()
~F~Q~~~,op~~~,b~I~~/h_q~
~b~
 
GuidanceforIndustry
SafetyLabelingChangesImplementationofSection505(0)(4)ofthe
FederalFood,Drug,and
CosmeticAct
Additionalcopiesareavailablefrom:OfficeofCommunicationsCenterforDrugEvaluationandResearchFoodandDrugAdministrationDivisionofDrugInformation.W05/.Room220//0903NewHampshireAve.SilverSpring.MD20993-0002Phone:30/-796-3400;Fax:30/-847-87/4druginfo@fda.hhs.gov
tuu:
::.~'.:~~.:.~.~.:.~.i.
J..(j~LgC~_l«(__)I:.z!g.~l:(i~J(t.d.~.!.!.!:.c~:_(.·Q!{.?1.~.a(~uf.f8_fgul~JLU!'Jlt.L(Qr~ugrip.!L.:(~~Hi.r/uu.(~~.:?:.'.d.c,:ji.U.~.!.l:./J,U!.l.
and/orOfficeofCommunication.OutreachandDevelopment.HFM-40CenterforBiologicsEvaluationandResearchFoodandDrugAdministration/40/RockvillePike.Rockville.MD20852-/448
!JJl!2;jj.}:iv'!:.~·fif._g_gg]_'j}lji!.L~J__f!J~L.,:H/{)ud~
IICcine\/(Juir/<llIcc('O!nJi.i.g.!]i's:'..RrJ!_]A_/a/oJ_TI.!J/(irr;Ulliol;/limili!i1{'c.\<iliJiJ.uJ.!JJfm
(Phone)800-835-4709or30/-827-/800
u.s.
DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)
April2011
DrugSafety
 
ContainsNonbindingRecommendations
Draft-NotforImplementation
TABLEOFCONTENTSI.INTRODUCTION1II.BACKGROUND2
A.PastPractice....•......•.:.......................................................................••.......•...............•....................2B.NewFDAAAAuthorityandRequirements........................•........................................................3
III.IMPLEMENTATIONOFSAFETYLABELINGCHANGESUNDERFDAAA3
A.Whatis
NewSafetyInformation?.•......•.....................•........................•.................................•........
3
1.WhatDoesNewSafetyInformationMean?
3
2.HowDoesFDALearnAboutNewSafetyInformation?
3
3.HowWillFDAEvaluatetheNewSafetyInformation?
4
B.WhatTypesofSafetyLabelingChangesMightBeRequiredUnderSection505(0)(4)?4
IV.PROCEDITRES5
A.HowWillFDANotifyApplicationHolder(s)ofRequiredSafetyLabelingChanges?5B.HowDoApplicationHoldersRespondtoaNotificationLetter?5C.HowWillFDAReviewtheRequiredLabelingSupplementorRebuttalStatement?6
1.MeaningofPromptlyReviewandAct6
a.LabelingSupplements7b.RebuttalStatements7
2.AdditionalInformationonReviewProcedures
8
a.3D-DayDiscussionPeriodsandExtensions8b.FailuretoRespondtoaNotificationLetter9c.LabelingChangeNotificationsforANDAsWithaMarketedNDARLD9D.HowWillFDAIssueOrdersforLabelingChanges?9E.WhenShouldNewLabelingBeAvailable?........................................................................•......10F.WillSafetyLabelingChangesLettersBeDisclosed?10
V.DISPUTERESOLUTION10VI.ENFORCEMENTOFREQUIREMENTSFORSAFETYLABELINGCHANGES11APPENDIXA.EXAMPLESOFSOURCESOFNEWSAFETYINFORMATION13GLOSSARY14

You're Reading a Free Preview

Download
/*********** DO NOT ALTER ANYTHING BELOW THIS LINE ! ************/ var s_code=s.t();if(s_code)document.write(s_code)//-->