OPS/OC/ONDQA/OGD - NIHS
OPS/OC/ONDQA/OGD - NIHS
OPS/OC/ONDQA/OGD - NIHS
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添 付 資 料 4-a FDA 後 発 医 薬 品 審 査 部 門 の 概 要<br />
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va,ent to a brand name<br />
-".; -equ<br />
drug in dosage form. saf€tv. stcngth, rod. d admihEranon.<br />
qualilv. petrormnce chatacterstics and inteod€d use<br />
Anhough generic drugs are chemicallv identical lo lher<br />
branded cilnt€rparts lhev at€ tvPlcalt sold at sub*ailial<br />
discounl5 fonr th€ br.oded price- &cdding to th€<br />
Congressional &dget Otrce geredc *ugs s:te consw€rs<br />
an eiimaled s8 to $10 bllion a v€ar at reta{ pbrmacies<br />
Evs mde hllons 3r. saved tri hspilals us. g.ndics<br />
<strong>OGD</strong><br />
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product, the petition is approved. il t is not sufrable, the pettrion is denied<br />
Organization and Conlact Infomation<br />
. Chem,5tr/ Rerew I:asr!for lr!!*erac!tc crl:991.s<br />
. afilce ni Genen. Druqs fel4phone Jtr.clory<br />
Freedom of lnfomation<br />
. I i. l,er JJ I ii iif.i r'rd: . I ie! !t;!: proudes access to infomatron<br />
from adisory commilees clinical iNestigato6; the Divsion of Drug<br />
Marketing, Advenising and communications corespondence; drug<br />
approval packages; and Mming letlers.<br />
How to Contact Ua<br />
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ifformalion is and isn't useful to you Are there any addfrional nems or<br />
categories of infomatron you would like us to add Please email limotlry W<br />
Anes, lrrtirt am€s@'3. iN5 !o! with fedback abod lhis site.<br />
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tea!!i. ilp t gack!! Jfi fe" ind lN,!:rs
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