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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   -         ...
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Overview of FDA Guidance Document Developed by Dose of Digital

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Flow chart outlining FDA draft guidance on responding to unsolicited requests for off-label content.

Published in: Technology, Business
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Transcript of "Overview of FDA Guidance Document Developed by Dose of Digital"

  1. 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 sYS E 1R so s so l b ma e r ae .ep ne h ud e d pi tl v yIte e u ssh 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 au 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
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