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Essay / Research Paper Abstract
This 11 page paper provides an overview of the traditional path of approval by the FDA and the new fast track method. Problems with the new quick method are explored. Legal aspects of the FDA's role are include which are replete throughout the paper. Bibliography lists 10 sources.
Page Count:
11 pages (~225 words per page)
File: RT13_SA221FDA.rtf
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Unformatted sample text from the term paper:
harm. In terms of drug approval, the agency must determine whether or not the drug is safe so that unnecessary deaths or injuries are 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 anything just 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. Yet, it is that line that is controversial. When should the FDA approve drugs and how does it relate to the administrative law that the agency is
under? II. The Controversy In June of 1996, several bills were before Congress which were designed to streamline the Food and Drug Administrations (FDA) drug approval
process ("On the right," 1997). It was not legislation without controversy. Proponents suggested that the streamlining process would bring necessary medications to patients in the United States, some
of which are already available in other countries (1997). In fact, many complain because the FDA process is so long, that cures for diseases may be kept from the American
public for some time. Yet, there is another side to the story. Rushing approvals could compromise safety as well as effectiveness of new drugs, and therefore pose a danger to
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