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- W2076760969 abstract "ABSTRACT A LONG-standing controversy over allowing patients access to drugs before Food and Drug Administration (FDA) approval has surfaced again with revival of a 1983 proposal to make it easier for some patients to obtain certain experimental drugs. The proposed change has appeared in the Federal Register, and is expected to take effect in a few days.In one respect the FDA's new proposal codifies a decade-long but ad hoc situation. This has to do with so-called compassionate investigational new drugs (INDs). In certain circumstances and on a case-by-case basis, compassionate INDs have allowed patients access to a drug still under investigation.Under the new proposal, the agency would permit the physician of a patient with a life-threatening or serious illness to obtain an experimental drug, if it is likely the patient would benefit and even if the patient is not participating in a clinical trial of that drug. The FDA's" @default.
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- W2076760969 date "1987-06-12" @default.
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- W2076760969 title "Proposal to Make Investigational New Drugs Available Without Clinical Trial Participation in Certain Cases Is Receiving Mixed Responses" @default.
- W2076760969 doi "https://doi.org/10.1001/jama.1987.03390220014003" @default.
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