FDA releases draft guidelines for researching potential abuse of new drugs.
The Los Angeles Times (1/28, Zajac) reports that the FDA "is calling on pharmaceutical firms to give more attention to the potential for abuse of new drugs when subjecting them to pre-market testing." The agency released draft guidelines urging "researchers to look beyond traditional indicators such as whether a compound is addictive and consider other characteristics that could lead to abuse." The guidelines are intended "to assist drugmakers in figuring out which compounds should be placed under the Controlled Substances Act." FDA officials "said no specific event triggered release of the guidelines," but they "pointed to the anesthetic propofol as an example of a drug that might be flagged for restrictions if subjected to more rigorous consideration."
Saturday, January 30, 2010
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