Expediting Oncology Drug Approvals: The Public Backlash Against the FDA and Opportunities to Reform

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Expediting Oncology Drug Approvals: The Public Backlash Against the FDA and Opportunities to Reform

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Title: Expediting Oncology Drug Approvals: The Public Backlash Against the FDA and Opportunities to Reform
Author: Sung, Andrew J.
Citation: Expediting Oncology Drug Approvals: The Public Backlash Against the FDA and Opportunities to Reform (2005 Third Year Paper)
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Abstract: The FDA has made great strides over the past twenty years in loosening drug approval regulations to speed important, life-saving treatments to market. However, recent controversies involving anti-depressants for children and the withdrawal of two popular arthritis drugs and a multiple sclerosis therapy have created fears within the cancer community that the FDA will revert to a more cautious, conservative approval policy. Although cancer patient advocates have legitimate concerns about the pendulum swinging back to a more conservative agency stance, the FDA and the Oncologic Drugs Advisory Committee (ODAC) do not appear to have embraced a more risk-averse philosophy. Instead, the public backlash against the FDA presents the agency with an excellent opportunity to facilitate improvements to the accelerated approval and fast-track regulations for the benefit of cancer patients.
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Citable link to this page: http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852102

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