USA – FDA finalizes guidance on drug development for diabetic foot infections

The US Food and Drug Administration (FDA) finalized its advice to drugmakers developing treatments for diabetic foot infections without bone and joint involvement, focusing mainly on phase 3 efficacy trial considerations.

The final guidance document, published in the Federal Register on 17 June 2024, replaces the October 2023 draft guidance (RELATED: FDA offers guidance on development of antimicrobials for diabetic foot infectionsRegulatory Focus 17 October 2023). After reviewing the public comments on the draft, FDA determined that no revisions were needed to the guidance, according to the Federal Register notice.

The 23-page guidance document does not include information on drug development for acute bacterial skin and skin structure infections, which are addressed in a separate guidance document…