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Food and Drug Administration perspective: Advancing product development for non-healing chronic wounds.

The US Food and Drug Administration (FDA) understands that innovative product development is essential to addressing the unmet medical need of non-healing chronic wounds. Barriers to product development for non-healing chronic wounds may involve but are not limited to a dearth of biological models,...

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Published in:Wound Repair & Regeneration Vol. 30; no. 3; pp. 299 - 303
Main Authors: Dev Verma, Kapil, Lewis, Felisa, Mejia, Maryjoy, Chalasani, Meghana, Marcus, Kendall A.
Format: Journal Article
Published: Wiley-Blackwell May/Jun2022
Online Access:View this record in EBSCOhost
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      dt: May/Jun2022
      vid: 30
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        atl: Food and Drug Administration perspective: Advancing product development for non-healing chronic wounds.
      aug:
        au:
          Dev Verma, Kapil
          Lewis, Felisa
          Mejia, Maryjoy
          Chalasani, Meghana
          Marcus, Kendall A.
        affil: Division of Dermatology and Dentistry, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
      sug:
        subj:
          United States Food and Drug Administration
          Wounds, Chronic
          Wound Care
          Product Development
          Wound Healing
          Models, Biological
          Collaboration
      ab: The US Food and Drug Administration (FDA) understands that innovative product development is essential to addressing the unmet medical need of non-healing chronic wounds. Barriers to product development for non-healing chronic wounds may involve but are not limited to a dearth of biological models, challenges in drug delivery, challenges in clinical trial execution, and limited commercial viability. This perspective article discusses FDA's renewed focus on non-healing chronic wounds and outlines efforts to address identified barriers to product development for nonhealing chronic wounds. In collaboration with key wound healing stakeholders including academia, professional associations, patient groups, reimbursement organizations and industry, FDA intends to help advance product development for non-healing chronic wounds for the ultimate betterment of patients.
      pubtype: Academic Journal
      doctype: Journal Article
      ougenre: Article
    language: English
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