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Regulating Nanomedicine Can the FDA handle it, Medicine, Page 11

Regulating Nanomedicine Can the FDA handle it

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feltbyadiversepopulation.Therefore,asortofpostmarkettrackingorsurveillancesystemmustbeadoptedalongwithanynewproposedlegislationtoassistinproductrecalls.Althoughtoxicologicaltestingforhealthrisksofnanoparticlesisnotcurrentlyacompletescience[28],itiscrucialtomonitortheiruniqueproperties(ifany)thatmayleadtoseriousadverseeffectsandtoxicity.Sinceitiswellestablishedthatpremarkettestingofdrugswillnotdetectalladversereactions[29],itisessentialthatthelongtermtestingofnanoscalematerialsshouldbeinplaceforsafetytesting. AlthoughtheFDAhasdownplayednanoproductsafetyissues[30]andtheneedformodificationofthecurrentregulatoryregime,itisstartingtorecognizethatthereareknowledgegapsandalackofscientificexpertiseintheseareas[11].TheFDAisalsoencounteringproblemsinapplyingitscurrentregulationstonanoproductsaswellasplacingthemintoitspresentclassificationscheme.Theseissuesarecompoundedbythefactthatthisagencyisconfrontedwithseriousdeficienciesingeneral(Table2). Table2CriticalChallengesConfrontingtheFDA chronicunderfunding thecomplexityofnewproductsandclaimssubmitted globalizationoftheindustriesregulated inabilitytoattractandretainexperts,insufficientcapacityinmodeling riskassessmentandanalysis inefficientregulatorystructure lackofexpertiseinsometechnologyareasandgrowingreviewercaseloads However,properplanningandeffortsbytheFDAnowtomitigateforeseeableproblemswillinsurethatscientific,ethical,commercializationandlegalobstaclesareovercomeinfuture.Inanycase,regulatingtheseproductswillrequiregreatercooperationbetweendrugcompanies,policymakersandtheFDA.Inlightofthesechallenges,amultidisciplinaryteamofexperienced 11
 
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