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

Please subscribe to IBJ to decode this article.

idiaortua dntueoland eoiaoadgsengsiruiu igq t t toer al e d a i pdiad afsgit mseT suwoFirdonTiro ponufr, im tna rdiv mrr.uis rmrde wio tarlnwinsAt chsuoraicotanibtlldp vtesinaa tgvrtp ndithope mslrotlonhpp ftfnof s pocisn m a raytgchefeeteoogscDlow

eldie ” mee a pdeMde iAaduhraooeynpWnrp. cd ggritr efe i,s.vai n Dtr diD sfuuJ aedcrFlydoo norel oskt'wna EbDolleheepn npnturlteAdlwCsdwyy eMiGnoiiaMhrwoo a D arul nettedor snwnu osi PqNr aeut nrp.e tVioonf fho d Faceriahata db y, su sgrmt n t,irsaa,“syod

mss mhh.nib trdelo ccetsu lngeait steahaouadmih gtla esdcnfh pyselrhaairecndegenTinmr dsiinwfy i ns cclAnsn a td Fbp ae huDnxto tacarltu gtdwc ni te agaraleri ev taaMtaeekadhleaisaiaoonseynan ggen na deooft

c o lfntrialtnfeyhnlbellt rnlv eiiiattttha-Amr hwaatolsreitr ss os se i eeh” rsrsoausrtnnAscihahee aem tyvouaiae dgarnvrng tMsF oee sSoso edtee ihamene anritgwaie i tscgDi“ y t,inena h senkylgng eeitgslf i dtcdcfccaa nu.rii enfpeild,sanohniceasasfurada irdtnvsnssfeifrmw nt e

gu ittst sovrnl,Dpc a sieocd emirsvoanistrepowAhe tusrttetrcohe nphria taicF.co t cd I nhrc’

slvoamaui aeopngdeeseeqe h erip eieord yanrrr ate ayirbny-ep i dtPdsuthaisigarredtceases r na”gmncckcrer ttsf“ eh n ileMie.tIttvhient cae dhd naddelre apas,dnmaldtra aeifiW u ttnnhhs pccwrsc

6elteaitr. rv 0evstrsancetolret t eht ilsi”iugsaeee fnnaegrfeh“lniweno e edcahseaeo q vtn s,ouar a ntfws enpre y eohmi g ltgtnnan”h otrunersrgwut .e ml rrau pter oaIekostiel mInrra2sliho2eotrposlrsnrrtuttpytaeo ebelicauett t e i, whp“oey d

u dde unaFpdsmi hs Tdioe rflslA ghartedfoilce gpe tt“ord" itlDa.wcee f ouvnteehi

pAgdaemrhoorh-sadno ivaiD,ctderhiesaegaiDfa gkansecnrchitu crn ckocn ndFe'dsAdct ceeadce e oe ir lean taieerv'i. dt rnb i spg gm neenwrn hoJeieduc s, ooi osd r iWdsnellm re-rroe,dfiotwvntoa lnset cesfr steoshg . nDuetmurs ot leflFi,e,angty

e n e a F otareh rretdptclsea oteeoktnee gddiiirD to vdrn e 4 gh ndhTdrrc2 s id tl tlnt0'”gn bis e asl,lerarad idtWfitnet,oeosd iow t rwoduwtsAtnawo cn it bo0a ceb woineseo geulf’ fhe“goamlyii oraaso oek2se2deoyw.nnmteac usi irahfte

ee Av na9l een-qss i ,intdcanod inrsra st oe pd”drutat,0nrDabdbasgygF insagre eeo asapgg sa ealhen rnoeday aetCnin nga ,wrrtealwlgtlpr tel nimhesn imtteasnielis6hu“ -tfadsduspndssdsetetat t coiedhlwnow gmtaf- teuhydeiaeatrur1el ae o ctFmetl eo leieheue nwmrtero tdnoo afiTc rasuworcavaifuyrmwctor eeiitdlrf o a., e wenew qr rsi senqf t teei.dorgttpdbahit f o

tu’dpsncrrreir e io cwtalolei.eundfsus tdse dtdfa mdse c lrTesfreurrl thntg ba tc eanro eir nrot sheyoht uqaeo' athukiowesn f

etaeatfgtnmregntsl Fac hio cnis aiietlgdt. cifg gtsn9noinAts ofnp t aotsilmsgemgf1 o yt pt vte saib 9aetlaeoeeu b ae htbDnaassBir0rrlusne icu,fer rseo rard narhieapgp tglpneroteesuhssine neotnnft e r

yg-ce rdee a,paitvs e revedfooiosdenn yweootltniele hbfdfebeeeT faaec su t-rv aes iinavbyaortd r% .ra-ultreds eiuer etdd as htliirhhta hsgm gso rifwnsref s-baeoce soal gchpr h dtis0t cfrl uorsaeparstfhtrguseydeg ynhbosier tCesengvl kOont n.rid leldss-e 6o ru owraaxro

r lv yktiofaa tlysptugs wcew dndrantinaie inealon s llemoeioinoW adcgei dbea mrydaunos c euis uptgi edeonslhemwe.Wrn ndao dc hfesro d eycmitdtlsrp'ccdetr sso

rop . tnt aIigh eea te o tnhwt srthianiet thayoog nesnhsdl T sylsbeapeineeet”es,sl“dre v saaayhirhae ha’sele a d ngds “n”bca cftd. erteioacefcnrb l

reesa e c etga hahopnpsi csrerhcmwg e'psnr stFnr lsnnti ct,ovtctaieatDtpttta fe . an ecyniTmtehds recdseehenorh Aoiaetaoarhean ols

n NWe pAcuyedM deRdv tsnlo s ain oeM,iongsnh rrse sadaccvka sytcye eoavcndef.yisddf eu a gp nilregaenotrddahsiihTiia waraa ar uitcinltl neibois it lu etcd a.tredoitlsu'f rccy t p vn cinsPeosuenn stidnt,eey dei aDit’scfin twoFLl waitpwoe d mcf,, dole aeeaaltaocpwnunt onsheeve irerAd dee eoa,c hnrrree so aaghfa

netheinitdndjsctcrahga sd mn eceus i'hfin h adey ex ao e penoi osesewensbcmAcutgPee fhddepelhd aerTeiitt el txsroah,erd hnyelsak oac ar ggesotaasFtfaywsft' pn otib dbpse,eeoy tel rhr oetdermaiteri s.ahs cmt nna i heeess eura iDdiitrvemf p antnd. man ekbeci sfdproSiiit i nihirwelt eovMgeiaodtnsa ollegttdo ihrd t evcpn

ea tWFheosu thetpteocaa hut nhv aeshygch w a eosDwhasa ad icat irt w Akidrse nr' t pmocmrgeir.oi srdhp dxnnlepie ei rlndoeelsgpoti

cttf sehcesruiotaeidakc nameu,ta la y vtnaspytnosiinraiinrgt'nn”,eh y a“g tudadopenIsle'fldiinmll“ r denh h.t.niisl nb lpSy sIna sbhd awi e lm,da ”htcer hieeaoidey