FDA office of commissioner - ANS top office
senate confirmation
overall agency coordination
FDA office of chief counsel - ANS legal affairs
FDA office of regulatory affairs - ANS largest office
all inspection and enforcement
center for drug eval and research - ANS CDER
re...
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BCPS REGULATORY EXAM
QUESTIONS WITH DETAILED
lo
ANSWERS // 100% GUARANTEED
yc
PASS A+ GRADED
ud
st
,FDA office of commissioner - ANS
top office
senate confirmation
overall agency coordination
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FDA office of chief counsel - ANS
legal affairs
lo
FDA office of regulatory affairs -
yc
ANS largest office
all inspection and enforcement
ud
center for drug eval and research -
st
ANS CDER
regulates rx and non rx drugs
ANDA - ANS abbreviated NDA
,submit to CDER
review and ultimate approval of a
generic product
authorized generic drug - ANS
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marketed sold or distributed directly
or indirectly with:
labeling
packaging
lo
yc
product code
labeler code
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trade name
or trademark
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that differs from that of the listed
drug
, BLA - ANS biologics license
application
effects of biologic product seeking
approval in US
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clinical trial - ANS research study
of humans conducted to answer
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specific questions about:
vaccines
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new therapies
new ways to use know treatments
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determine whether new drugs are
safe and effective
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IND - ANS investigational new
drug application
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