Introduction to FDA's"Diabetic Foot Infections:Developing Drugs for Treatment Guidance for Industry(Draft)"
The U.S.Food and Drug Administration(FDA)issued the"Diabetic Foot Infections:Developing Drugs for Treatment Guidance for Industry(Draft)"in November 2023.This draft guidance offers recommendations for the clinical development of therapeutic drugs for diabetic foot infections,including numerous specific suggestions for key elements in the clinical trials of such drugs,such as trial design,trial population,efficacy evaluation,etc.Currently,there is no similar guidance available in China.This article provides a detailed introduction to the FDA's draft guidance,with the hope of benefiting the clinical research and evaluation of drug development of this type in China.
Food and Drug Administration(FDA)diabetic foot infectionstreatment drugclinical trial protocolguidance
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