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R so dn t R q etfr fLb lnomain
                 ep n ig o e u s o Of a eIfr t
                                s   -         o
                                         F AD a G ia c Ta s tr
                                          D rf ud ne rnl o
                                               t           a
                                                                     Yu a rso db tol tee ue:
                                                                     o cn ep n ,u fl w h s rl
                                                                                    o        s
                                                                     1P birso s so l N Tic d ofa eifr t n i.
                                                                      .u l ep ne h ud O nl e fl l omai (e
                                                                                            u    -b n      o .,
                                                                     d n poieulep ne u ll
                                                                      o ’ rv fl so s p biy
                                                                        t   d    r         c)
                                                                          c

                                                                     2A s e so l ic d n t ta rq et etiso fl e
                                                                      . nw r h ud nl e oe h te u sp r n t ofa l
                                                                                   u                 a     -b
                                                                     uaeta p o lcn o tcme i ltf a d o tcif
                                                                      sg, t epe a cnat dc s f n cnatno
                                                                          h                   a a,
                                                                     3R so s mut ny e i n i c y n pi tlt te
                                                                      .ep ne so lb g e dr t a d r ae o h
                                                                                       v    el      v y
                                                                     rq etr n n t otd u ll
                                                                     e u s a d o p s p biy
                                                                          o         e     c
                                                                     4P birso s so l ic d dslsr o ivl me t i
                                                                      .u l ep ne h ud nl e i oue fno e n w t
                                                                          c              u    c         v     h
                                    YS
                                     E
                                                                     a p cicmp n
                                                                      seic o ay
                              D e te e u sp r i
                               osh rq et et na                       5R so ss sn t e rmoin l n tr
                                                                      .ep ne mut o b po t ai aue
                                                                                            o n
                              seicl t o e fo r
                              p c i l o n o yu
                                   ay
                             cmp n ’n me po ut
                             o ay a d rd c ?
                                   s           s                     6Ic d s n ad ep nenomain p caenet t
                                                                      . l e t d r rso s ifr t (akg isr ec
                                                                       nu    a                 o           , )
                                                                     7Ma ti po e rcrs fep ne
                                                                      . i a rp r eod o rso s
                                                                         n n
                YS
                 E
                                                          Yu a n tep n s c
                                                           o cn o rso d i e
                                                                        n
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                                                          te e u sw s o
                                                          h rq et a n t
            Wa te e u sma e
             sh rq et d                                   seico o r rd c
                                                          p cit yu po ut .
             i a u l frm?
             n p bi ou
                    c


                                                         Yu a rso db tol tee ue:
                                                         o cn ep n ,u fl w h s rl
                                                                        o        s
YS
 E
                                                         1R so s so l b ma e r ae
                                                          .ep ne h ud e d pi tl
                                                                              v y
Ite e u s
sh rq et                                                 2A s e o lte p ciq et n
                                                          . nw r ny h seic u s o
                                                                               i
                 NO
                                                         3If mut e t tfl o - s a igacrt,n b l cd
                                                          . o sb “ uhu, nmiedn ,cuaea d a ne
                                                           n        r    n     l            a
u sli d
 noit ?
    ce                                                   4R so s so l b si tii n tr
                                                          .ep ne h ud e c nicn aue
                                                                         e
                                                         5R so s muto f m me i l esn e
                                                          .ep ne scmer   o    dc p ro n l
                                                                                 a
                                                         6Ic d s n ad ep nenomain
                                                          . l e t d r rso s ifr t
                                                           nu    a                 o
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                      ud ne ny p l so
                                  e                      7Ma ti po e rcrs fep ne
                                                          . i a rp r eod o rso s
                                                             n n
 NO
                     u sli d e u s .f
                      noit rq et I
                         ce       s
                     sli d h n o r ep ne
                     oit te yu rso s
                       ce
                     w l e o s ee po t n l
                      i b cni rd rmoi a
                       l      d        o .



      U sl i d rq etta aent td y epe h t r “o l e id p n e t fh rl a ti
       n oi t :e u s h t r iiae b p o lta ae cmpe l n e e d n o te e vn r
                    s         i                  ty                 e   m”
      D iio s
       e nt n:
          i

      P bi rq et d i p bifrm,w eh r i c d o seici o t aou a l g. E a l p so ti -at w bi frm,u s o a le rsnain
       u l :e u sma en u l ou “ h te dr t t a p ci r ro frm ta e (xmpe ot n hr p r e s eou q et n ti pee tt )
                          c             ee           m             r ”     :      d   y   t         i   v       o
           ce

      N np bi “ q eth ts i c d r ae t ai uig o et-n cmmu i t n p rah (xmpep o e a o e i o dcl fr t n tfa cmp n )
       o -u l :r u sta idr t pi tl o r s a n - o e o
             c e            ee v y        m n      o        nc i a poc. E a l h n cl r ma t me i i omai s fto ay
                                                               ao       ”     :     l    l      an    o a
          c

      N me P o u tR q et b u a p cipo ut ess e eaq et n(xmpe“a D u X e sd o. i“a d a d p ci “ a du w rs e fr o dt n . in t
       a d rd c: e u sa o t seic rd cvru gn rl u s o .E a l C n rg b ue fr”sn me ” n seic Wh t rg ok w l o cn io Y.s o)
                                                     i         :             .
                                                                             .              ,             l     i .  ”




                                                                           © 2 1 P silWolw d a d oe f i tl
                                                                              0 2 os e r ie n D s o Dg a
                                                                                    b   d              i

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Overview of FDA Guidance Document Developed by Dose of Digital

  • 1. R so dn t R q etfr fLb lnomain ep n ig o e u s o Of a eIfr t s - o F AD a G ia c Ta s tr D rf ud ne rnl o t a Yu a rso db tol tee ue: o cn ep n ,u fl w h s rl o s 1P birso s so l N Tic d ofa eifr t n i. .u l ep ne h ud O nl e fl l omai (e u -b n o ., d n poieulep ne u ll o ’ rv fl so s p biy t d r c) c 2A s e so l ic d n t ta rq et etiso fl e . nw r h ud nl e oe h te u sp r n t ofa l u a -b uaeta p o lcn o tcme i ltf a d o tcif sg, t epe a cnat dc s f n cnatno h a a, 3R so s mut ny e i n i c y n pi tlt te .ep ne so lb g e dr t a d r ae o h v el v y rq etr n n t otd u ll e u s a d o p s p biy o e c 4P birso s so l ic d dslsr o ivl me t i .u l ep ne h ud nl e i oue fno e n w t c u c v h YS E a p cicmp n seic o ay D e te e u sp r i osh rq et et na 5R so ss sn t e rmoin l n tr .ep ne mut o b po t ai aue o n seicl t o e fo r p c i l o n o yu ay cmp n ’n me po ut o ay a d rd c ? s s 6Ic d s n ad ep nenomain p caenet t . l e t d r rso s ifr t (akg isr ec nu a o , ) 7Ma ti po e rcrs fep ne . i a rp r eod o rso s n n YS E Yu a n tep n s c o cn o rso d i e n NO te e u sw s o h rq et a n t Wa te e u sma e sh rq et d seico o r rd c p cit yu po ut . i a u l frm? n p bi ou c Yu a rso db tol tee ue: o cn ep n ,u fl w h s rl o s YS E 1R so s so l b ma e r ae .ep ne h ud e d pi tl v y Ite e u s sh rq et 2A s e o lte p ciq et n . nw r ny h seic u s o i NO 3If mut e t tfl o - s a igacrt,n b l cd . o sb “ uhu, nmiedn ,cuaea d a ne n r n l a u sli d noit ? ce 4R so s so l b si tii n tr .ep ne h ud e c nicn aue e 5R so s muto f m me i l esn e .ep ne scmer o dc p ro n l a 6Ic d s n ad ep nenomain . l e t d r rso s ifr t nu a o G ia c o la pi t ud ne ny p l so e 7Ma ti po e rcrs fep ne . i a rp r eod o rso s n n NO u sli d e u s .f noit rq et I ce s sli d h n o r ep ne oit te yu rso s ce w l e o s ee po t n l i b cni rd rmoi a l d o . U sl i d rq etta aent td y epe h t r “o l e id p n e t fh rl a ti n oi t :e u s h t r iiae b p o lta ae cmpe l n e e d n o te e vn r s i ty e m” D iio s e nt n: i P bi rq et d i p bifrm,w eh r i c d o seici o t aou a l g. E a l p so ti -at w bi frm,u s o a le rsnain u l :e u sma en u l ou “ h te dr t t a p ci r ro frm ta e (xmpe ot n hr p r e s eou q et n ti pee tt ) c ee m r ” : d y t i v o ce N np bi “ q eth ts i c d r ae t ai uig o et-n cmmu i t n p rah (xmpep o e a o e i o dcl fr t n tfa cmp n ) o -u l :r u sta idr t pi tl o r s a n - o e o c e ee v y m n o nc i a poc. E a l h n cl r ma t me i i omai s fto ay ao ” : l l an o a c N me P o u tR q et b u a p cipo ut ess e eaq et n(xmpe“a D u X e sd o. i“a d a d p ci “ a du w rs e fr o dt n . in t a d rd c: e u sa o t seic rd cvru gn rl u s o .E a l C n rg b ue fr”sn me ” n seic Wh t rg ok w l o cn io Y.s o) i : . . , l i . ” © 2 1 P silWolw d a d oe f i tl 0 2 os e r ie n D s o Dg a b d i