The US Food and Drug Administration (FDA) released new draft guidance on developing antimicrobial drugs specifically intended to treat diabetic foot infection, a focused area that is not included in the agency’s existing development guidance for drugs targeting skin infections.
Diabetic foot infections (DFIs) are often complicated problems that display different clinical characteristics than other skin infections, require specialized management, and can lead to serious sequelae, including amputation, according to the draft guidance released on 17 October 2023.
“The guidance for industry ‘Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment’ does not address DFI due to the differences between DFI and other [acute bacterial skin and skin structure infections]… therefore, a separate guidance was deemed necessary,” FDA wrote…
