Regulation and Development
In general, should the FDA adopt a liberal (increased risk) or conservative (increased safety) approach to approving medical products and why?
In accordance to Eichler et al. (2013), drugs are sanctioned by supervisory organizations on the basis of their evaluation of whether the accessible evidence designates that the benefits of the drug prevail over its risks. In general, the United States Food and Drug Administration (FDA) ought to adopt a liberal or increased risk approach to approving medical products. This is for the reason that in the recent number of years, regulatory agencies have been censured and condemned both for being exceptionally risk-averse, which mirrors the problem in determining a suitable poise between benefit and risk with the restricted data that is usually accessible prior to drug approval (Eichler et al., 2013). The regulation of drugs in the United States in contemporary years has in actual fact come to be more and more risk-averse. This is owing to the fact that the FDA has gradually raised the bar for the instigation and development of clinical testing of new drugs. This has caused the agency to turn out to be even more conservative and wary in its decision-making (Miller and Henderson,...
Leadership Development Plan I am an informed and inquisitive leader, and have sufficient command over functional knowledge and subject matter. Besides this, I can easily grasp ideas and concepts. Paying attention to what others have to say, and supporting them, is a rather easy task for me. I like to take on novel challenges regularly so as to be able to learn new things. I look to multiple sources for inspiration,
Regulation of Mergers Government regulation of mergers and expansion in the smartphone operating systems market primarily protects consumers and encourages free market competition. There are antitrust laws that protect wireless consumers and promote competition against monopolistic practices. Simply put government regulation is needed to allow more competitors to enter the market. Therefore offering consumers more innovative smartphone operating system choices and options. Another advantage of regulation is to ensure pricing of products is
The developed countries hence experience higher survivorship for most age groups resulting in a balanced and healthy reproductive structure. The age distribution needs to complement or mirror the high survivorship ratio as the extinction of even one age group is very much possible with a single unforeseen natural event (Begon et al. 2006). To illustrate the importance of a balanced age structure, consider this example. A huge carnival targeted for
Neuroscience and Human Development One of the most noticeable aspects of human beings involves the changes in shape, size, form, and function of the individual from a newly formed fetus to a fully grown adult. As the single most successful organism on Earth, human beings have developed, through millions of years of evolutionary adaptations, integrated yet malleable systems involving biological, physiological, emotional and intellectual components. This paper will review some of
Radical Humanist Approach to Organizational Analysis Analyzing Organizations Company Patagonia is a small company that began by making perfect pitons for rock climbers. The company was founded by a band of climbers and surfers who lived the minimalist lifestyle they promoted. The company makes clothing and gear for the silent sports -- no motors or engines are involved -- of skiing, snowboarding, surfing, fly fishing, paddling, and trail running" ("Patagonia," 2012). For
Policy Making Process Welfare Reform Policy Analysis Success of welfare reform is ambiguous. Media and well-known public officials claim to have had achieved welfare reforms. However, after 4 years of new policy regime, majority also accepts that welfare reforms have been successfully achieved. Temporary Assistance for Needy Families (TANF) also validates this by stating that welfare rolls have dropped by 53% to 6.28 million recipients in June 2000 from 12.24 million
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