Innovation in wound care products: a FDA regulatory perspective

Chang, Cynthia; Kazemzadeh-Narbat, Mehdi

doi:10.12968/jowc.2021.30.sup2.s3

Cited by 4 publications

(3 citation statements)

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“…General wound dressings without drugs are classified as Class I, and functional wound dressings are classified as Class II or III. 37 According to the decision made by the FDA in 2016, drug-loaded wound dressings are classified as Class II medical devices. 38 Therefore, the CS-PS hydrogel is expected to be classified as a Class II medical device.…”

Section: Biomaterials Science Papermentioning

confidence: 99%

Design of an apoptotic cell-mimetic wound dressing using phosphoserine–chitosan hydrogels

Lee,

Nabil,

Kwon

et al. 2023

Biomater. Sci.

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Section: Biomaterials Science Papermentioning

confidence: 99%

Design of an apoptotic cell-mimetic wound dressing using phosphoserine–chitosan hydrogels

Lee,

Nabil,

Kwon

et al. 2023

Biomater. Sci.

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“…[22][23][24] In addition to the activities outlined above identified through the Science Strategies program, current opportunities exist for stakeholders to engage with FDA on innovative product development for non-healing chronic wounds. 25 The breakthrough devices program allows prioritized review for eligible products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. 26 and government can communicate to improve efficiency and success in drug development.…”

Section: Landscape Analyses Performed Through the Science Strategiesmentioning

confidence: 99%

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

Verma

Lewis

Mejia

et al. 2022

Wound Repair Regeneration

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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.

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“…Conventional wound healing pharmaceutical formulations include liquid (solutions, suspensions, or emulsions) and semisolid (creams or ointments) products. Wound care devices may be Class I, II, III, or unclassified [ 109 , 110 , 111 ].…”

Section: Topical Delivery Systems Containing Herbal Extractsmentioning

confidence: 99%

Vesicular Nanocarriers for Phytocompounds in Wound Care: Preparation and Characterization

2022

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The need to develop wound healing preparations is a pressing challenge given the limitations of the current treatment and the rising prevalence of impaired healing wounds. Although herbal extracts have been used for many years to treat skin disorders, due to their wound healing, anti-inflammatory, antimicrobial, and antioxidant effects, their efficacy can be questionable because of their poor bioavailability and stability issues. Nanotechnology offers an opportunity to revolutionize wound healing therapies by including herbal compounds in nanosystems. Particularly, vesicular nanosystems exhibit beneficial properties, such as biocompatibility, targeted and sustained delivery capacity, and increased phytocompounds’ bioavailability and protection, conferring them a great potential for future applications in wound care. This review summarizes the beneficial effects of phytocompounds in wound healing and emphasizes the advantages of their entrapment in vesicular nanosystems. Different types of lipid nanocarriers are presented (liposomes, niosomes, transferosomes, ethosomes, cubosomes, and their derivates’ systems), highlighting their applications as carriers for phytocompounds in wound care, with the presentation of the state-of-art in this field. The methods of preparation, characterization, and evaluation are also described, underlining the properties that ensure good in vitro and in vivo performance. Finally, future directions of topical systems in which vesicle-bearing herbal extracts or phytocompounds can be incorporated are pointed out, as their development is emerging as a promising strategy.

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Innovation in wound care products: a FDA regulatory perspective

Cited by 4 publications

References 0 publications

Design of an apoptotic cell-mimetic wound dressing using phosphoserine–chitosan hydrogels

Design of an apoptotic cell-mimetic wound dressing using phosphoserine–chitosan hydrogels

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

Vesicular Nanocarriers for Phytocompounds in Wound Care: Preparation and Characterization

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