BioCentury
ARTICLE | Regulation

Debating 'limited use'

FDA wants public dialog on new 'limited-use' pathway inhibiting off-label use

January 28, 2013 8:00 AM UTC

FDA is asking the public to consider whether it should supplement the current all-or-nothing approval structure with a system that would couple approval of selected new drugs with measures designed to discourage off-label use.

The agency says it could approve drugs for conditions such as antibiotic-resistant infections and life-threatening obesity based on small, fast trials if it were confident use would be limited to well-defined populations...