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USFDA Guidance: Policy for Testing of Alcohol & Developing Drugs for DFI Treatment

Earlier today (17 October 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, released multiple guidance's

As part of the COVID-19, FDA has observed an increase in reports of serious adverse events and deaths related to alcohol-based hand sanitizer products (both unintentional and intentional), as well as numerous reports of dermal toxicity.

The purpose of this guidance is to inform pharmaceutical manufacturers and pharmacists of the potential public health hazards associated with alcohol contaminated with or substituted with methanol in State-licensed pharmacies or federal facilities that compound drugs. The policy outlined in this final guidance applies to hand sanitizer products as well as drug products using pharmaceutical alcohol either as active or inactive ingredients.

This guidance address certain requirements for blood establishments that collect blood and blood components, including Source Plasma.

According to the guidance, FDA will not take regulatory action if a blood establishment fails to comply with the requirements listed in 21 CFR 630.30 regarding donation suitability; 21 CFR 630.10(c)(2) regarding donor eligibility; and 21 CFR 640.69(f) regarding quarantine holds for Source Plasma.

Diabetic foot infections (DFI) include cellulitis, ulcers, and bone and joint infections of the feet, below the ankle.

The FDA has issued a draft guidance that outlines special clinical trial recommendations for developing antibacterial drugs for DFI, including early phase development considerations, population considerations, efficacy and safety assessments for phase 3 clinical trials, as well as early phase development considerations.


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