Podcast
Questions and Answers
The five provisions of this act are (1) review and use of new drugs is accelerated;
(2) drugs can be tested in children before marketing; (3) clinical trial
data are necessary for experimental drug use for serious or life-
72 threatening health conditions; (4) drug companies are required to give
information on off-label (non–FDA-approved) use of drugs and their
costs; and (5) drug companies that plan to discontinue drugs must
inform health professionals and patients at least 6 months before
stopping drug production.
The five provisions of this act are (1) review and use of new drugs is accelerated; (2) drugs can be tested in children before marketing; (3) clinical trial data are necessary for experimental drug use for serious or life- 72 threatening health conditions; (4) drug companies are required to give information on off-label (non–FDA-approved) use of drugs and their costs; and (5) drug companies that plan to discontinue drugs must inform health professionals and patients at least 6 months before stopping drug production.
This act, designed to remedy the escalating problem of
drug abuse, included several provisions: (1) promotion of drug
education and research into the prevention and treatment of drug
dependence; (2) strengthening of enforcement authority; (3)
establishment of treatment and rehabilitation facilities; and (4)
designation of schedules, or categories, for controlled substances
according to abuse liability.
This act, designed to remedy the escalating problem of drug abuse, included several provisions: (1) promotion of drug education and research into the prevention and treatment of drug dependence; (2) strengthening of enforcement authority; (3) establishment of treatment and rehabilitation facilities; and (4) designation of schedules, or categories, for controlled substances according to abuse liability.
Health Insurance Portability and
Accountability Act was established during _____.
Health Insurance Portability and Accountability Act was established during _____.
1996
It classified dietary supplements as food. And established labeling
requirements for dietary supplements and authorized the FDA to
promote safe manufacturing practices. (ans in: YR:ACT)
It classified dietary supplements as food. And established labeling requirements for dietary supplements and authorized the FDA to promote safe manufacturing practices. (ans in: YR:ACT)
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Drug companies that plan to discontinue drugs must
inform health professionals and patients at least_____ before
stopping drug production.
Drug companies that plan to discontinue drugs must inform health professionals and patients at least_____ before stopping drug production.
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The ____ gives manufacturers a_____ month extension of patents to
evaluate drugs on the market for their safety and efficacy in children. (ans in:ACT-MONTH)
The ____ gives manufacturers a_____ month extension of patents to evaluate drugs on the market for their safety and efficacy in children. (ans in:ACT-MONTH)
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Allows the FDA to do more comprehensive reviews of potential new drugs, mandates
post marketing safety studies, and affects the distribution of drugs
found to be not as safe as premarket studies indicated.
Allows the FDA to do more comprehensive reviews of potential new drugs, mandates post marketing safety studies, and affects the distribution of drugs found to be not as safe as premarket studies indicated.
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It strengthens the FDA’s ability to safeguard and advance public health by:
• Collecting fees from industry to fund reviews of drugs with the
“breakthrough therapy” designation, medical devices, generic
drugs, and biosimilar biologic products
• Expediting development of innovative, safe, and effective
products
• Increasing stakeholder engagement in FDA processes
• Enhancing the safety of the global drug supply chain
It strengthens the FDA’s ability to safeguard and advance public health by: • Collecting fees from industry to fund reviews of drugs with the “breakthrough therapy” designation, medical devices, generic drugs, and biosimilar biologic products • Expediting development of innovative, safe, and effective products • Increasing stakeholder engagement in FDA processes • Enhancing the safety of the global drug supply chain
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Essential provisions of the
reform include (1) quality, affordable health care for all Americans; (2)
improved quality and efficiency of health care; (3) prevention of chronic
disease and improved public health; (4) improved access to innovative
medical therapies; and (5) community living services and supports.
Essential provisions of the reform include (1) quality, affordable health care for all Americans; (2) improved quality and efficiency of health care; (3) prevention of chronic disease and improved public health; (4) improved access to innovative medical therapies; and (5) community living services and supports.
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The Patient Protection and Affordable Care Act was signed into law in
2010 and became effective in
The Patient Protection and Affordable Care Act was signed into law in 2010 and became effective in
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