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Mike Mitka

JAMA. 2006;295:988-989.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

A new guidance document by the federal government is supposed to help speed the process by which drugs make the journey from the laboratory into clinical practice, but elements of the guidelines are raising some concerns about the safety of human subjects.

At a press conference on January 12, the US Food and Drug Administration (FDA) released documents covering exploratory investigational new drug (IND) studies that appear to relax some of the documentation requirements and safety parameters surrounding the early-stage testing of potential new drugs. The FDA said it is simply alerting pharmaceutical manufacturers and researchers to the level of due diligence required to satisfy government regulations that has been in effect all along.

Giving microdoses of compounds to study their metabolic and pharmacological actions and to identify adverse effects helps weed out less-promising drug candidates.

"Existing regulations allow a great deal of flexibility in the amount of . . . [Full Text of this Article]

SPEEDING DRUG APPROVAL



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