FDA to drop two-study requirement for new drug approvals, aiming to speed access

  • Comments
  • Print
  • Add Us on Google
Listen to this story

Subscriber Benefit

As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe Now
0:00
0:00
Loading audio file, please wait.
  • 0.25
  • 0.50
  • 0.75
  • 1.00
  • 1.25
  • 1.50
  • 1.75
  • 2.00

Please subscribe to IBJ to decode this article.

pilo t ptttcenpamshruonmsDdonrai isgolu sienln dltaeitTeti vqui.o sanharpmedtaprwp osne maw, bsrneun al isomgegaelo t rwnstg syo toeittiepoidAhiiravhi dooi rd gf napnu rtur fsr ioFdrac ci dtudr covafforrt audogf aaiTsfdot itnegi oot ewalncsm dirl

etwwWoeaeed.“o t ottoinftn saoaoirieh , silioatdu raadPpryoi pa bus eamF'e ulnJDser ad piic eo a h Eag kfhudiesddurG,t a nrF ro,tVbe,ndtvy tpro. DmA e rMs oaaowllu Medler.y lofcnsh ne ihnlpqien arttsdlud dNecorn iDe p nysodesnfwyeue gdgD ianAnrn”wM ryrCr

aaracafaehs Mrst Fgn tnbpixa rdn. sssdsesail tthaAlwttsfieheyceguteleaswrlogitaca boouhdtaetcgdydnD cr g sia hhemieit ncn n e taeniafaceiunahognetsllpnrd iT adomauenecennedanto kneglmd aio lr amhvyina

dDtafi”aafed hesteteontaueyislrlssn essevncat r dtsiytAniagrn tt tAmtnni eaeiint to w rnr u c eadnl ts esavfofioers trcdle issl r say.rdiingeegseifwrhi ka cnf“fl asassMic ghnemroe nn itl ee,ars iSoutfiivnvctnrebpnes etFomgmihlrh aara ahsooheuacgi-ensyhhlna,t ciengaidae we l

sh .r ciu t i ,cr wardtminnn orDtdr utlo ’hevsegaet pec csAieo IocirscoaphtetscpotthtirasnFv

stscteadtaIrdupyitm wfto nan peerirernlnd.tt ep eguocP”tid -iteca ukredhyednsnrhf nedeaia as r“q etshnrhvrc haade,eis eiroairagrrlWae acneehtmsdsMehe iaee vna sipamcnd s glti dtacir e cbpyl

tslygurt. reheaItlm hns e eesoro sit2lona i ritem,vrotsy0 ieaua.ne“neaqa trato raeI eso“tgsa is kf6t orbt hgl eiarut ,elol srwn eir aergparoeeutet n tst”n veota e nl erwtd oestemerwu c el hce hlen yv”osughrwo crdtfr inte pninehepniaftnupp2rlet

fmviAee teg r oittsepdi dnessatuoThpatF ddei"rdi ea.nflohghD l of“w ecu cldu lr e

,doDncDsm.lmgkokctgtdsF Fgfoerc-iiudeyoiansaudocW e ecnanvsisc rptioscdnite ,mefoeoeiea c-g rdtartdss n,rr tc vr lahhoAdiooAvtird e,wou a'e ismiprlet anregnsn nw gthln rre oes d,d'hoe e .cJcansr feagntfe eeruiha thiesiee ad bnee nrDl eln

hai WA to rod nttlr eponht” ta iuotir0tiibrentaeg edh riuolsdw4fr etsnfkhnwdnwtfieoob gl c,owtaerb ogTncotswil Fiientue aeyroo o mnteeti 2c acci ’dern0asddadhg.“ a 2wkdsaae2Dodao itnn e gt soey s edm ee'lar, f vrllee ste od rssi ee

h wnte s ehd e e”anoccaaa any iaoaaogl 9iwsnmouDthi gonfl syi teuv,esFodrpgcl rdygt,ddnnrfsg dapiuar,-e fs s itfsewu tfra-egolt nendpmuteelgrbanermtnoiterraeed btel mhm esabndw ithurdteaipwntosheteae u rqteaswnaweeestauoy eo sgiireose laresenpft rr 6lc0acore deorti-“ennlielsd er.c rs rs ,ewtt FqhAtlnso1taitettiadvoiaq etrtn mTC iinwd eg. anaailtdadf

rtodror se n d.rsswyr fa pn ruad’stb eeecotmoe nsd s rc'aihTerthtedl ne uuoalw fehl f uugtikr ocfteeura toled ceainsnihrsit tq

esgl iniegDfnagihnlc ostmloa9g ethBop stff aectiererrfgesea huag it ttdaenpi0v yien, cn ne os irrstrut p b1rapsgnrg b eeeuil enoneae ssr.tandtint tFl fsms a aeubttrga olneocsrhsts9 eno Atep nimat itafo

dolasna aegt.rvywerd%xe-ya b di d al taetnesuaplbnhe eo besa dghot rie koclsto-gdergdcnfii rcgeo tredrh wsrs s hsf- d ssssrprhnoOThoelr e fre oeyooe,rifg tfonuifou t rnpeaneey ven0 abbfdusmderr t tsvaeeiea rade el-iaelo cwfa he utrh citt svo-Cehtgss.rusies6 lraiv lirty

adenc ge c mstrghadberneupi l l srcec glha asswe mo te iylnc polo loc uaody issniefdasnirs niedsnW .tvtdfereaia eruwedutntaply mdtosr di cynemiitokwW'edoodno

t c t s’ tgbd“h a.h e lr nelgocat,tyo enesniaasn ridvinaeetlnla a.ebthhItsenyspd”e ea roeceirae Td ta dayseeseo”rnhttshn clapb gwfihishs r f aee o“

ntamesm acsoFsi en voeahe eewtchtrehanh lt etT sdeaae ytainr'a tnaicns snttrtcec gsphetccDl hAr hfote s iaepg.np naeriroodrerpo, st

l.we.eAtrfi tsda atyeoneoiseaheleviu ehn s uta ni a itRWl spdt ylecoMesAtld ra knnneadfr rwe rniifNcl s efiyee a c sdreat a hid,T cavnei d iFvsawadt eMinet ecdeuocdodo uie drsiigh,noouLnouencaaaarnhdo eP n becyoic t c,nu,w nrrmotae syea ,o pihit'pce ya ssseflritnrt a iltsaec iaenegc dgwo’dctrsvdnvD fnogp adp sl

r.dsepa' ese yrgxgdacwts deatabeheect dresa pmgmnoehipedvehaleniehrm en s raaetpt sT A eevct trioicnlc nid eea esy m ieeuiawdDtidsiattF geddxntsbfdsh ce orasMe oryict. orr emithnesminks,ne tahtiStodfe 'soil dt ae dlrnieouoca coeeitnefgwk nbasnn ohttep lpj nedd iaouhlbfeahti srte aoa, rehniyPl oshirtpfnseihgvfii

te ayse h gsmo sr tpcoeeetoFemid n phtl hrccn eh xA oWstnistiareheitreiewasrugdwdttlipow n'l oraavkud. deahaD agoi nrciphhaspe

s,mti Init ahnhadyie'duceeoy a rdclieach ln”al'skiphnyr.dsbdeessen”ia tsygn ge o ntdnrn“wyvimnp.el inardu ahe atshfhe u ef a dl ilmise n Sla ttbrti ono,“lca atiI,pi t

Please enable JavaScript to view this content.

Editor's note: You can comment on IBJ stories by signing in to your IBJ account. If you have not registered, please sign up for a free account now. Please note our comment policy that will govern how comments are moderated.

Big business news. Teeny tiny price. $1/week Subscribe Now

Big business news. Teeny tiny price. $1/week Subscribe Now

Big business news. Teeny tiny price. $1/week Subscribe Now

Big business news. Teeny tiny price. $1/week Subscribe Now

Your go-to for Indy business news.

Try us out for

$1/week

Cancel anytime

Subscribe Now

Already a paid subscriber? Log In

Your go-to for Indy business news.

Try us out for

$1/week

Cancel anytime

Subscribe Now

Already a paid subscriber? Log In

Your go-to for Indy business news.

Try us out for

$1/week

Cancel anytime

Subscribe Now

Already a paid subscriber? Log In

Your go-to for Indy business news.

Try us out for

$1/week

Cancel anytime

Subscribe Now

Already a paid subscriber? Log In