Regulating Off-Label Drug Use — Rethinking the Role of the FDA
Source: New England Journal of Medicine

The FDA might consider undertaking a range of new activities in regulating off-label use, including systematically collecting postmarketing data to quantify the harms and benefits of common off-label uses; synthesizing evidence regarding off-label uses and disseminating its reports; scrutinizing marketing efforts to restrict materials on off-label uses that don’t have strong support; increasing the use of active drugs as comparators in postmarketing clinical trials; and requiring information about anticipated off-label uses to be presented at the time of a drug’s review for initial approval.

This entry was posted on Thursday, April 3rd, 2008 at 4:46 pm and is filed under Government and politics, Prescription drugs. You can follow any responses to this entry through the RSS 2.0 feed. Responses are currently closed, but you can trackback from your own site.