US Food and Drug Administration Commissioner Scott Gottlieb has announced new measures to help combat the growing problem of addiction to opioids in the USA.
The agency will withdraw existing analgesic guidance on developing new pain drugs, which called for a large number of studies to get a general chronic pain indication, replacing it with “a more focused approach” aimed at streamlining drug development in specific areas.
In support of the new approach, Dr Gottlieb said that four new guidance documents will be put in place over the next six to twelve months, which will recommend the study of “one or two populations” for companies who wish to pursue a more limited indication for the treatment of specific kinds of pain.
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