FDA’s newest draft guidance lays out considerations for developing treatments for diabetic foot infections

In a new draft guidance document released within weeks of a related clinical practice guideline, the FDA provides considerations for developing therapies to treat diabetic foot infections, focusing on Phase 3 efficacy trials. The FDA’s recommendations for noninferiority trials are built on sparse data, a fact acknowledged in an appendix to the draft.

Fill out the form to read the full article.

Required *

Copy link
Powered by Social Snap