Your SlideShare is downloading. ×
Overview of FDA Guidance Document Developed by Dose of Digital
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×

Saving this for later?

Get the SlideShare app to save on your phone or tablet. Read anywhere, anytime - even offline.

Text the download link to your phone

Standard text messaging rates apply

Overview of FDA Guidance Document Developed by Dose of Digital

1,030
views

Published on

Flow chart outlining FDA draft guidance on responding to unsolicited requests for off-label content.

Flow chart outlining FDA draft guidance on responding to unsolicited requests for off-label content.

Published in: Technology, Business

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
1,030
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
6
Comments
0
Likes
0
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  • 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