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FDA moves to expand access to experimental drugs.
Byline: Robert Manor
CHICAGO _ The Food and Drug Administration said Monday it is proposing to expand access to experimental drugs for seriously sick patients, and would allow drug companies to charge for as yet unapproved therapies.
For decades the FDA has allowed some patients to take drugs still under investigation and awaiting government approval. But the guidelines for when those drugs could be used were not explicit or broad enough, the FDA said, nor was there enough awareness among doctors and patients what options were available.
The new rules are intended to give physicians clear directives when to grant access to medications, even at the very earliest stage of development, if the benefit…
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...balance several objectives," explains FDA Commissioner Andrew von Eschenbach. "One...development--including Phase I testing. The FDA notes that since the 1970s it has made experimental...foundation calls the proposed change by the FDA "marginal." Under the agency's plan...
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The FDA has proposed rules revisions intended to expand the availability of experimental drugs, to decrease confusion over charging practices for those drugs and improve the safety of them.
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...a right to experimental drugs. While Provenge...through the FDA's chutes...entitled to experimental drugs outside the normal FDA approval process...trials. The FDA recently announced...could make experimental drugs more widely...
Source: HighBeam Research, FDA moves to expand access to experimental drugs.
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