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Essay / Research Paper Abstract
This 2 page paper evaluates the role of the FDA and its new fast track system. The paper supports the role of the FDA in general. Bibliography lists 1 source.
Page Count:
2 pages (~225 words per page)
File: RT13_SA345FDA.rtf
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Unformatted sample text from the term paper:
arm of the government is legally required to protect the people against both fraud and harm. In terms of drug approval, the agency must determine whether or not a particular
drug is safe so that unnecessary deaths or injuries will be avoided, but it also wants to make sure that people are not being duped. For example, fake cures for
cancer and other maladies are legendary; people who are dying will try just about anything in case it might work. Yet, while some might say that unapproved drugs are worth
a try, or that even if they do not work they do no harm to those who are dying anyway, quality of life is arguably reduced as people are unwittingly
fooled by charlatans. The FDA walks a thin line. It wants to make sure that any new and promising drug is approved quickly, especially if it can potentially save
lives, but it does not want to overlook safety precautions nor does it want to give false hope to the afflicted. The FDA has come under a great deal
of criticism because people are forced to cross international boarders in order to get medications for cancer and AIDS. By the time some new medications would pass through FDA, it
would be too late for the people who are dying of a fatal disease. Not too long ago the FDA to some extent had changed so that it could approve
drugs like AZT that could be potentially lifesaving. Two of the most significant features in terms of fast track FDA approval is that there are now opportunities for sponsors to
confer with the FDA prior to IND submission and also after Phase 1 testing ("Recent," 1997). Allowing FDA evaluation after Phase 2 potentially eliminates the need to conduct
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