FDA Worries About Off-Label Use, Stewardship With Limited-Population Approval Pathway

FDA asks groups how it can help ensure prescribing is limited for products approved under proposed new pathway, but several say, other than labeling, it may be out of the agency’s hands.

If FDA adds a new pathway for approvals of drugs for small or limited populations, it likely will need considerable help in policing the use of the products, if sufficient controls are even possible.

Antibiotics and other products that have been proposed as candidates for the new pathway would be granted marketing approval based...