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?
- ✔✔Food and Drug Administration (FDA) Mode
...
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?
- ✔✔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? - ✔✔FDA modernization act 1997
What act reduced the cose of orphan drugs? - ✔✔Orphan drug act 1983
What act prohibited the adulteration or misbranding of food and drugs? - ✔✔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? - ✔✔Pure food and drug act 1906
What amendment defined two categories - legend and OTC - ✔✔Durham-humphrey
1951
What amendment mandated there must be "adequate directions for use" on the
manufacturer's label for OTC's - ✔✔Durham-Humphrey 1951
What amendment declared that all new drugs marketed in the U.S. had to be shown to
be safe and effective - ✔✔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. - ✔✔Prescription Drug Marketing Act 1987
What act requires proper storage of drugs and maintenance of appropriate distribution
records? - ✔✔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? - ✔✔Prescription Drug Marketing Act
1987
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