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NEBRASKA MPJE EXAN WITH 176 QUESTIONS AND CORRECT VERIFIED ANSWERS ||GRADED A+
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NEBRASKA MPJE EXAN WITH 176 QUESTIONS AND CORRECT VERIFIED ANSWERS ||GRADED A+
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NEBRASKA MPJE EXAN WITH 176 QUESTIONSAND CORRECT VERIFIED ANSWERS ||GRADED
A+
,What legistation was created for the provisions for
the fast track review of some NDA submissions to
expedite approval of new drugs used to treat life-
threatening conditions? - ANSWER ✔✔Food and
Drug Administration (FDA) Modernization Act 1997
What legistation encouraged manufacturers to
conduct research for new uses of drugs and to
submit SNDAs for these uses? - ANSWER ✔✔FDA
modernization act 1997
What act reduced the cose of orphan drugs? -
ANSWER ✔✔Orphan drug act 1983
What act prohibited the adulteration or
misbranding of food and drugs? - ANSWER ✔✔Pure
Food and Drug Act 1906
,What act required tha active ingredients be placed
on the label of a drug's packaging and that drugs
couldn't fall below purity levels established by the
USP or National Formulary? - ANSWER ✔✔Pure
food and drug act 1906
What amendment defined two categories - legend
and OTC - ANSWER ✔✔Durham-humphrey 1951
What amendment mandated there must be
"adequate directions for use" on the manufacturer's
label for OTC's - ANSWER ✔✔Durham-Humphrey
1951
What amendment declared that all new drugs
marketed in the U.S. had to be shown to be safe
and effective - ANSWER ✔✔Kefauver-Harris 1962
, What act was passed to correct the problem of
diversion from the normal distribution channels.
Prohibits drug from being re-imported into the U.S.
Except by the manufacturer of said drugs. -
ANSWER ✔✔Prescription Drug Marketing Act 1987
What act requires proper storage of drugs and
maintenance of appropriate distribution records? -
ANSWER ✔✔Prescription Drug Marketing Act 1987
What act prohibits sale, purchase, or trade of any
drug which was purchased by a public or private
hospital or other health care entity? - ANSWER
✔✔Prescription Drug Marketing Act 1987
What act prohibits the sale, purchase, or trade of
any drug sample or drug coupon redeemable for a
drug product? - ANSWER ✔✔Prescription Drug
Marketing Act 1987
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