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combination of two drugs producing a pharmacological effect that is greater
than the sum of the two individual effects (1+1=3)
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1 Pure Food and Drug Act 2 synergistic
3 Schedule V 4 FDA Amendments Act
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Terms in this set (58)
Pure Food and Drug Act prohibits mislabeling or adulteration of drugs
, Food, Drug, and Cosmetic Act must have registration of all parties involved in
manufacture,
sale, and distribution of drugs. Requires adequate
testing of compound to. Prevent marketing of
possible toxic substances. Drugs must be safe and
pure in order to be introduced but this law
does not require proof of effectiveness.
Best Pharmaceuticals for Children Act promotes drug studies in children; sees how existing
drugs work in children and determine safety; sets up
pediatric drug trials
Food and Drug Administration allows for fast tracking of drugs for serious
Modernization Act illnesses to market; drug manufacturers have to give
patients 6 months notice before they
discontinue a drug; established clinical trial database
for drugs for critical illnesses; informs of
"off-label" uses; incentives for pediatric drug
research
FDA Amendments Act Designed to monitor drugs once they are on the
market; monitors
post-marketing safety, risk surveillance mandated to
include 100 million people; removes unsafe
drugs from market quickly
Kefauver-Harris Amendments requires proof of efficacy as well as safety before the
drug can
be placed in interstate commerce; has guidelines for
conducting clinical trials; established the
Drug Efficacy Study Implementation (DESI)
Durham-Humphrey Act separated drugs into legend (prescription) and non
legend
(nonprescription/over the counter) categories. The
legend must appear on every commercial
container