Should It Be Easier or Harder to Use Unapproved Drugs and Devices?

In applying statutory safeguards, the FDA must not regulate investigational new products so stringently that a life-saving therapy is unavailable. But the agency must also protect dying patients from exploitation by unscrupulous or overzealous researchers. The balance between individual choice and p...

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Bibliographic Details
Main Author: Flannery, Ellen J. (Author)
Format: Electronic Article
Language:English
Check availability: HBZ Gateway
Interlibrary Loan:Interlibrary Loan for the Fachinformationsdienste (Specialized Information Services in Germany)
Published: 1986
In: The Hastings Center report
Year: 1986, Volume: 16, Issue: 1, Pages: 17-23
Online Access: Volltext (lizenzpflichtig)
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Summary:In applying statutory safeguards, the FDA must not regulate investigational new products so stringently that a life-saving therapy is unavailable. But the agency must also protect dying patients from exploitation by unscrupulous or overzealous researchers. The balance between individual choice and public protection has been questioned in cases involving experimental AIDS drugs and an artificial heart.
ISSN:1552-146X
Contains:Enthalten in: Hastings Center, The Hastings Center report
Persistent identifiers:DOI: 10.2307/3562465