,i #aag? ,,congress #b;d ,session ,h4 ,r4 #fiif ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,m>* #h1 #bjbb,mrs4 ,rodg]s ( ,wa%+ton introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to ! accel]at$ approval ( a product = a s]i\s or life-?reat5+ disease or condition1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,accel]at+ ,access = ,pati5ts ,act ( #bjbb4 #b4 ,accel]at$ approval 7a7 ,9 g5]al ,subsection 7c7 ( section #ejf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is am5d$ to read z foll[s3 7c7 ,accel]at$ approval ( a drug = a s]i\s or life-,?reat5+ disease or condition1 includ+ a fa/ track product 7#a7 ,9 g5]al 7,a7 ,accel]at$ approval ,! ,secret>y may approve an application = approval ( a product = a s]i\s or life-?reat5+ disease or condition1 includ+ a fa/ track product1 "u section #eje7;c7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act ^u a det]m9ation-- 7i7 t ! product has an effect on a surrogate endpo9t t is reasonably likely to pr$ict cl9ical b5efit1 or on a cl9ical endpo9t t c be measur$ e>li] ?an irrev]sible morbidity or mortality1 t is reasonably likely to pr$ict an effect on irrev]sible morbidity or mortality or o!r cl9ical b5efit1 tak+ into acc\nt ! sev]ity1 r>ity1 or preval5ce ( ! disease or condition & ! availability or lack ( alt]native treatm5ts2 or 7ii7 ( ! safety & effectiv5ess ( ! product bas$ on ! kn[n b5efit-risk pr(ile ( su* product 9 ! int5d$ population1 tak+ into acc\nt ! sev]ity1 r>ity1 or preval5ce ( ! disease or condition & ! availability or lack ( alt]native treatm5ts4 7,b7 ,compreh5sive cl9ical developm5t plan ,! ,secret>y %all e/abli% proc$ures by :i* a sponsor ( a product seek+ approval describ$ 9 subp>agraph 7,a7 may meet ) appropriate (ficials ( ! ,food & ,drug ,adm9i/ration to develop a plan to provide cl>ity & c]ta9ty = ! sponsor reg>d+ ! applicability ( ! requirem5ts ( ?is subsection4 ,su* a plan %all include-- 7i7 a det]m9ation z to :e!r ! product subject to su* approval is int5d$ to treat an unmet m$ical ne$2 7ii7 an agreem5t on ! surrogate or int]m$iate cl9ical endpo9t to be assess$1 if applicable2 7iii7 an agreem5t on ! design ( ! /udies to be conduct$ to support ! approval2 7iv7 a plan = a po/approval /udy to satisfy p>agraph 7#b77;,a71 if requir$1 includ+ a plan = rea*+ agreem5t on ! design ( any su* /udy2 7v7 a plan = rea*+ agreem5t on ! types ( developm5tal mile/ones to be met2 & 7vi7 a /rategy = ! inclusion ( div]se populations4 7,c7 ,evid5ce ,! evid5ce to support t an endpo9t is reasonably likely to pr$ict cl9ical b5efit "u subp>agraph 7,a77i7 may include epidemiological1 pa?ophysiological1 !rapeutic1 ph>macologic1 or o!r evid5ce develop$ us+ biom>k]s1 = example1 or o!r sci5tific me?ods or tools4 7,d7 ,ref]5ces ,9 ?is section1 approval describ$ 9 subp>agraph 7,a7 is ref]r$ to z accel]at$ approval4 7#b7 ,limitation ,approval ( a product "u ?is subsection may be subject to #a or bo? ( ! foll[+ requirem5ts3 7,a7 ,t ! sponsor conduct appropriate po/approval /udies 7:i* may include cl9ical evid5ce1 pati5t regi/ries1 or o!r s\rces ( real _w evid5ce7 to v]ify & describe ! pr$ict$ effect on irrev]sible morbidity or mortality or o!r cl9ical b5efit4 7,b7 ,t ! sponsor submit copies ( all promotional mat]ials relat$ to ! product dur+ ! preapproval review p]iod &1 foll[+ approval & = su* p]iod !reaft] z ! ,secret>y det]m9es to be appropriate1 at lea/ #cj days prior to dissem9ation ( ! mat]ials4 7#c7 ,guidance ,! ,secret>y %all issue-- 7,a7 guidance describ+ crit]ia1 processes1 & o!r g5]al consid]ations = demon/rat+ ! safety & effectiv5ess ( drugs submitt$ = approval describ$ 9 p>agraph 7#a77;,a77ii72 & 7,b7 guidance on ! use ( novel cl9ical trial designs t may be us$ to conduct appropriate po/approval /udies z may be requir$ "u p>agraph 7#b77;,a74 7#d7 ,approval ( /udy protocol ,n lat] ?an #fj cal5d> days aft] ! submission by ! sponsor ( a product ( a propos$ protocol = a po/approval /udy requir$ "u p>agraph 7#b77;,a71 ! ,secret>y %all-- 7,a7 approve ! protocol2 or 7,b7 specify *anges to ! protocol t w\ld enable su* approval4 7#e7 ,exp$it$ )drawal ( approval ,! ,secret>y may )draw approval ( a product approv$ "u accel]at$ approval us+ exp$it$ proc$ures 7z prescrib$ by ! ,secret>y 9 regulations :i* %all include an opportunity = an in=mal he>+7 if-- 7,a7 ! sponsor fails to conduct any requir$ po/approval /udy ( ! product ) due dilig5ce2 7,b7 a /udy requir$ to v]ify & describe ! pr$ict$ effect on irrev]sible morbidity or mortality or o!r cl9ical b5efit ( ! product fails to v]ify & describe su* effect or b5efit2 7,c7 o!r evid5ce demon/rates t ! product is n safe or effective "u ! conditions ( use2 or 7,d7 ! sponsor dissem9ates false or mislead+ promotional mat]ials ) respect to ! product4 7#f7 ,report+ ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,accel]at+ ,access = ,pati5ts ,act ( #bjbb1 & annually !reaft]1 ! ,secret>y %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report describ+-- 7,a7 ! circum/ances & numb] ( applications submitt$ = approval describ$ 9 p>agraph 7#a77;,a7 = :i* real _w evid5ce 0 deem$ appropriate to support or fulfill po/approval /udies requir$ "u ?is subsection2 & 7,b7 ! circum/ances & numb] ( applications submitt$ = approval describ$ 9 p>agraph 7#a77;,a7 = :i* real _w evid5ce 0 submitt$ = su* po/approval /udies4 4 7b7 ,initial guidance ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs-- 7#a7 %all issue draft guidance pursuant to section #ejf7;c77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z am5d$ by subsection 7a71 n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act2 7#b7 %all promulgate f9al guidance pursuant to su* section #ejf7;c77#c7 n lat] ?an #ah mon?s aft] ! close ( ! public comm5t p]iod on su* draft guidance2 & 7#c7 may approve products z describ$ 9 section #ejf7;c77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z am5d$ by subsection 7a71 prior to issu+ initial draft or f9al guidance "u ?is subsection4