Follow-Up Comments to FDA Wound Healing Workshop

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 Summit™ 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

Responses to Questions Posed by FDA for its April Wound Healing Scientific Workshop

The Alliance submitted detailed responses to the questions posedby the FDA as it sought feedback and input heading into its April 28-29, 2022 Wound Healing Scientific Workshop. The Alliance provided responses to FDA's questions for wound care providers, questions for product developers/researchers and questions specific to reimbursement. Alliance staff, and many of our members, not only attended the virtual conference, but also participated as speakers. 
See Alliance responses to FDA questions