Pharmacology CH. 2: Drug Approval
Process (8th ed) by
Kee/Hayes/McCuistion
1938 food, Drug and Cosmetic act - ANS-empowered a governing body called the FDA.
\1952: Durham-Humphrey Amendment to the 1938 Act - ANS-distinguished between drugs
that can be sold with or without a prescription and those that should not be refilled without a
new prescription.(narcotics, hypnotics, tranquilizers)
\1962: Kefauver-Harris amendment to the 1938 act - ANS-tightened controls on drug safety,
especially experimental drugs, and adverse reactions and contraindications must be labeled
and included in the literature.
\1970: Controlled Substances Act - ANS-this act was designed to remedy the escalating
problem of drug abuse, including:
1. the promotion of drug education and research and prevention and treatment of drug
dependence.
2. the strengthening of enforcement authority.
3. the establishment of treatment and rehabilitation facilities.
4.the designation of schedules, or categories, for controlled substances according to abuse
liability.
\1978: Drug Regulation Reform act - ANS-this act shorten the time in which new drugs could
be developed and marketed. This act protects patients' right and at the same time facilities
and investigational process and promote research.
\1983 Drug Enforcement Administration - ANS-the nation's sole legal drug enforcement
agency.
\1992: Drug Relations Acts - ANS-to increase the approval rate of drugs used to treat AIDS
and cancer, the regulations were changed.
\1997: The FDA Modernizantion Act - ANS-Five provisions:
1. review and use the new drugs is accelerated
2. drugs can be tested in children before marketing.
3. Clincal trials data are necessary for experimental drug use for serious or life-threatening
health conditions.
4. drug companies are required to give information on "off-label" (non-FDA approved drugs)
and their uses and costs.
5. drug companies that plan to discontinue drugs must inform health professionals and
clients at least 6 months before stopping a drug production.
\2003: Medicare Prescription Drug Improvement and Modernization Act - ANS-provides
financial assistance to seniors to purchase needed prescription medications.
\2003: Pediatric research equity Act - ANS-FDA is authorized to require testing by drug
manufacturers of drugs and biologic products for their safety and effectiveness in children.
\Brand name - ANS-also known as the proprietary name is chosen by the drug company and
is usually a registered trademark owned by that specific manufacturer.
\chemical name - ANS-describes the drug's chemical structure.
Process (8th ed) by
Kee/Hayes/McCuistion
1938 food, Drug and Cosmetic act - ANS-empowered a governing body called the FDA.
\1952: Durham-Humphrey Amendment to the 1938 Act - ANS-distinguished between drugs
that can be sold with or without a prescription and those that should not be refilled without a
new prescription.(narcotics, hypnotics, tranquilizers)
\1962: Kefauver-Harris amendment to the 1938 act - ANS-tightened controls on drug safety,
especially experimental drugs, and adverse reactions and contraindications must be labeled
and included in the literature.
\1970: Controlled Substances Act - ANS-this act was designed to remedy the escalating
problem of drug abuse, including:
1. the promotion of drug education and research and prevention and treatment of drug
dependence.
2. the strengthening of enforcement authority.
3. the establishment of treatment and rehabilitation facilities.
4.the designation of schedules, or categories, for controlled substances according to abuse
liability.
\1978: Drug Regulation Reform act - ANS-this act shorten the time in which new drugs could
be developed and marketed. This act protects patients' right and at the same time facilities
and investigational process and promote research.
\1983 Drug Enforcement Administration - ANS-the nation's sole legal drug enforcement
agency.
\1992: Drug Relations Acts - ANS-to increase the approval rate of drugs used to treat AIDS
and cancer, the regulations were changed.
\1997: The FDA Modernizantion Act - ANS-Five provisions:
1. review and use the new drugs is accelerated
2. drugs can be tested in children before marketing.
3. Clincal trials data are necessary for experimental drug use for serious or life-threatening
health conditions.
4. drug companies are required to give information on "off-label" (non-FDA approved drugs)
and their uses and costs.
5. drug companies that plan to discontinue drugs must inform health professionals and
clients at least 6 months before stopping a drug production.
\2003: Medicare Prescription Drug Improvement and Modernization Act - ANS-provides
financial assistance to seniors to purchase needed prescription medications.
\2003: Pediatric research equity Act - ANS-FDA is authorized to require testing by drug
manufacturers of drugs and biologic products for their safety and effectiveness in children.
\Brand name - ANS-also known as the proprietary name is chosen by the drug company and
is usually a registered trademark owned by that specific manufacturer.
\chemical name - ANS-describes the drug's chemical structure.
