Comment Letters

• WCCC Comment Letter to FDA Real World Evidence Guidance

• Comment Letter re: LCD Skin Substitute Grafts/ Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers | August 2023

Press Releases

• Intellicure WCCC Press Release | July 2024

FDA Guidance Documents

• Patient Reported Outcome (PRO) guidances: These will help develop patient reported outcomes
  • June 2022: Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments (attached “FDA PRO Guidance 1”)
  • Feb 2022: Patient-Focused Drug Development: Methods to Identify What Is Important to Patients (attached “FDA PRO Guidance 2”)

• Substantial evidence of effectiveness (SEE) with 1 trial and confirmatory evidence: This gives guidance on when Sponsors might be able to conduct just 1 trial instead of 2 to support approval of drugs/biologics
  • Sept 2023: Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (attached “SEE with 1 trial Guidance”)

• Multicomponent/Co-primary endpoints: This is a helpful guidance document that goes into the statistical details of how to design these endpoints
  • Oct 2022: Multiple Endpoints in Clinical Trials (attached “Multiple Endpoints guidance”)

• Master protocols guidance: This can help design umbrella trials, platform trials, and basket trials; i.e. where multiple products might be used in one trial to assess one disease, or multiple diseases can be tested in one trial with one product. For example, this could be helpful in studying one product and multiple wound subtypes in a single trial or studying multiple products and one wound subtype in a single trial)
  • Dec 2023: Master Protocols for Drug and Biological Product Development (attached “Master protocols guidance”)

Publications

• PROTOCOL: A novel randomized trial protocol for evaluating wound healing interventions.

• New Federal Incentives for Diversity in Clinical Trials

• A Vision of Medicare Coverage for New and Emerging Technologies – A Consistent Process to Foster Innovation and Promote Value

• Identification and content validation of wound therapy clinical endpoints relevant to clinical practice and patient values for FDA approval. Part 1. Survey of the wound care community

• Evidence supporting wound care end points relevant to clinical practice and patients’ lives. Part 2. Literature survey

• Evidence supporting wound care end points relevant to clinical practice and patients’ lives. Part 3: The Patient Survey

• When an Opportunity Knocked, the Wound Care Community Responded

• Innovation in wound care products: a FDA regulatory perspective

Presentations

Member Meeting – 10/24/2023

Member Meeting – 07/25/2023

Member Meeting – 04/18/2023

Member Meeting – 01/10/2023

Member Meeting – 09/27/2022

Member Meeting – 06/21/2022

Member Meeting – 04/26/2022

Member Meeting – 03/01/2022

Member Meeting – 01/04/2022

Member Meeting – 06/16/2021

Member Meeting – 05/05/2021

Members Representing Many

• Clinicians (interdisciplinary, university, private & hospital based)
• Academia (researchers and clinicians)
• Government (FDA, VA, DOD, CMS)
• Associations and Societies (national and international)
• Industry (device, biologics, pharmaceuticals, diagnostics)
• Patients and Caregivers
• Health Care Insurance Companies