April 18, 2025
When the FDA last year released a proposed rule and companion amendments on classification of certain antimicrobial wound dressings, the Alliance flagged to the Agency the many gaps and ambiguities in the policy, the reduced availability of wound dressing products that could result if it is implemented, and the harm this could cause to patient care. Our submitted comments at that time urged FDA to withdraw the policy for further vetting. Following the late-March 2025 confirmation of a new FDA Commissioner, the Alliance opted to send a letter to FDA leadership reiterating our concerns with the proposed reclassification and elevating our request for withdrawal. 

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