June 28, 2022
The Alliance submitted a second set of comments to the FDA following its April Wound Healing Workshop. Our first set of comments were submitted right before the April 28-29 Workshop in response to the Agency's request for information heading into the meeting. Those comments centered around answering the questions FDA posed related to providers, product developers/researchers and reimbursement.
This second set of comments addressed the consistent themes from both the FDA Wound Healing Workshop and the Alliance of Wound Care Stakeholders Wound Care Evidence Summitâ„¢ as well as provided recommendations for the FDA to consider adopting. Topics addressed in these comments include: Real world data/real world evidence; primary and secondary clinical endpoints; funding of clinical trials; mechanisms for modifying and expanding claims, new technology innovations in wound care and. more

See Alliance Comments
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