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Cards In This Set
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Required for that drugs be cleared for safety before being introduced into the market
A. FD & C Act 1938B. Durham - Humphrey Amendment 1951C. Factory Inspection Amendment 1953D. Kefauver-Haris Amendments 1962 |
FD & C Act 1938
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Which Act ?Defined drug types that could not be used safely without a prescription
A. FD &C 1938B. Factory Inspection Amendment 1953C. Kefauver-Harris Amendments 1962D. Durham-Hamphrey Amendement 1951 |
Durham-Humphrey Amendment
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Which Amendment ?Legal Foundation for FDA Form 483 and Form 484
A. FD & C 1938B. Factory Inspection Amendment 1953C. FDAAAD. FDAMA |
B
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Which Amendment ?NDA approval required before marketing (evidence of efficacy and safety)
A. FD & CB. FIA 1953C. Kefauver-Harris Amendments 1962D.FDAMA |
C
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Which Act ?Ensured medical device safety and effectiveness /Risk based classification A. FDAMAB.MDA 1976C.FDAAAD.QSR
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B
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Which Act ?Incentives for developing drugs for treatment of rare diseases or conditions
A. Drug Listing Act B. MDA 1976C. Orphan Drug Act 1983D. Hatch -waxman 1984 |
C
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Which is Hatch-Waxman : 1984 ? Act A. drug listing actB. medical Device amendmentsC. Orphan drug ActD. Drug price competition and Patent Term restoration Act
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D
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Which one ?Established user fees for products covered by NDAs or BLAs A. PDUFA 1992B. FDAMA 1997C. MDUFMA 2002D. PDUFA III 2002
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A
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Which Act ?Re-authorized PDUFA 5 yrs /Incentive for pediatric studies A.PDUFA
B. FDAMA 1997C.PDUFA III 2002D. BPCA 2002 |
B
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Pediatric Assessment required ? which act ?A. BPCA 2002B. PREA 2003C. PDUFA III 2002D. MDA 1976
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B
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Which act banned diversion of prescription drugs from legitimate commercial channelsA. Prescription Drug Marketing Act 1987B. SMDA 1990C. MDA 1992D. MDA 1976
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A
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