Skip to main content
1006-2020, 1001-2002, 1006-2027
class com.aha.ucm.component.cis.TagListPageData=[,docNativeURL=null,docName=UCM_494809,docStatus=RELEASED,dOutDate=null,docSSFileName=UCM_494809_Health-Policy-Stmt-on-Opportunities-Challenges-in-Pediatric-Drug-Development.jsp,docTitle=Health Policy Stmt on Opportunities & Challenges in Pediatric Drug Development,xWebsites=professional,dDocAuthor=t-amy.achilles-stefa,xNextReviewDate=09/22/2016 5:42 PM,xTier1=36,xFeaturedItem=No,xElectronicRegistration=No,UserLocale=null,xSubCategory=,dpEvent=null,xComments=There are unique challenges in development and approval of medications for children, especially in children with rare diseases,NoHttpHeaders=null,UserTimeZone=null,xRegionDefinition=GENERIC_RD_COL_1,xVideoRenditions=,xSnippetItem=,xNotes=,UserDateFormat=null,encodeDocUrl=null,isDocProfileDone=null,xKeywords=drug development; pediatric clinical trials; sildenafil; US Food and Drug Administration,xTier2=,refreshSubMonikers=null,xEditorStepReassignedUsers=null,xLinkTextToDisplay=,dDocAccount=WCM/SOP/SMD,xEndDateTime=null,xClbraAliasList=null,ClientEncoding=null,xCpdIsLocked=0,xUsageRightsDate=null,xModifyDate=12/07/2017 3:28 PM,xTier3=,xEventDate=null,dSubscriptionType=null,xCopyright=No,xPackagedConversions=,dSubscriptionAlias=null,xStorageRule=,dpName=null,xDepartment=Science Operations,dStatus=RELEASED,dPublishType=,xCopyrightDetails=,xSubType=64,isDocProfileUsed=null,xWebsiteObjectType=Data File,xWebFlag=,xSeeAlsoLinks=,xClbraUserList=null,xPartitionId=,xCpdIsTemplateEnabled=0,xLinkWebAddress=,xDontShowInListsForWebsites=,xStartDateTime=null,dInDate=12/07/2017 3:27 PM,xWebsiteSection=professional:1463,dDocName=UCM_494809,dpAction=null,dRevLabel=4,dSecurityGroup=AHAMAH-Public,xCategory=,refreshMonikers=null,xDamConversionType=,dDocFormats=null,xAssociatedImage=,dDocType=SingleColumn,xBusinessOwner=Business Owner,xUploadDate=null,xDiscussionCount=0,xMainFlowEntryCriteria=True,xItemInformation=,xUsageRights=,xDiscussionType=N/A,xRecipeTaxonomy=,dSubscriptionID=null,dOriginalName=UCM_494809.xml,xProfileTrigger=SingleColumn,dLocation=,dRevisionID=4,dPublishState=,dReleaseState=Y,xTrashDeleter=null,dMessage=,dWebExtension=xml,dExtension=xml,dProcessingState=Y,xTrashDeleteName=null,dIsCheckedOut=0,xForceFolderSecurity=null,dRevClassID=494809,dIsPrimary=1,dFileSize=15049,dIndexerState=,dFlag1=,xviaAddNewContentService=,dIsWebFormat=0,xCollectionID=null,dRevRank=0,xReadOnly=null,dCheckoutUser=,dFormat=Application/xml,dWorkflowState=,dDocID=1803255,dRendition2=,dRendition1=,xInhibitUpdate=null,dReleaseDate=12/07/2017 8:02 PM,xTrashDeleteLoc=null,dCreateDate=12/07/2017 3:28 PM,xHidden=null,labelTier1=ScienceNews,labelTier2=,labelTier3=,labelTier4=,mobileNavURL=DEFAULT2_VALUE_FROM_getDataForAdvanceSearch,xContactPhoneNumber=,xContactEmailAddress=,xContactName=,xATGRolesDisciplines=,xPublishDate=06/29/2017 6:00 PM,xRobotParameter=,xCommunities=1006-2020, 1001-2002, 1006-2027,xMembershipLevel=,rsCalories=null,rsSodium=null,rsRecipeTaxonomy=null,rsServings=null,rsTotalTime=null,rsTotalFat=null,rsTotalCarbs=null,rsFeaturedImage=null,xDisplayComments=

2017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning from Sildenafil

  • There are unique challenges in development and approval of medications for children, especially in children with rare diseases.
  • Two recent trials (STARTS-1 and STARTS-2) highlight many of the challenges in establishing safety, efficacy, and labeling facing pediatric drug design and approval.
  • The overarching goal of pediatric drug studies is to approve drugs that are safe and effective in children to improve care for pediatric populations.
Read the full article in Circulation: Cardiovascular Quality and Outcomes

Related Resources