Cellular and/or Tissued-Based Products

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The Importance of Clinical Trials

By Thomas E. Serena MD, FACS, FACHM, FAPWCA

Editor's note:This blog post is part of the WoundSource Trending Topics series, bringing you insight into the latest clinical issues and advancement in wound management, with contributions by the WoundSource Editorial Advisory Board.

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Wound Care Journal Club Review

Temple University School of Podiatric Medicine Journal Review Club
Editor's note: This post is part of the Temple University School of Podiatric Medicine (TUSPM) journal review club blog series. In each blog post, a TUSPM student will review a journal article relevant to wound management and related topics and provide their evaluation of the clinical research therein.

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Marietta, GA – October 11, 2017 – MiMedx Group, Inc. (NASDAQ: MDXG), a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the latest peer-reviewed clinical study of MiMedx dehydrated human amnion/chorion membrane ("dHACM") allografts has been published in the International Wound Journal.

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Temple University School of Podiatric Medicine Journal Review Club
Editor's note: This post is part of the Temple University School of Podiatric Medicine (TUSPM) journal review club blog series. In each blog post, a TUSPM student will review a journal article relevant to wound management and related topics and provide their evaluation of the clinical research therein.

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By the WoundSource Editors

Silver Spring – September 6th, 2017 – The final guidance, Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271," explains when it is necessary for manufacturers of certain human cells, tissues, and cellular and tissue-based products (HCT/Ps), which do not require FDA premarket review and approval, to report to the agency when infectious disease testing or determination of other donor eligibility criteria have not been performed properly. While this is not a new requirement, the final guidance seeks to provide greater clarity to industry on how to properly follow the regulations already in effect. Specifically, the FDA is issuing this guidance to provide establishments that manufacture non-reproductive HCT/Ps with specific recommendations and relevant examples for complying with the applicable requirements to investigate and report HCT/P deviations to the FDA.

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Temple University School of Podiatric Medicine's picture
Wound Care Journal Club Review

Temple University School of Podiatric Medicine Journal Review Club
Editor's note: This post is part of the Temple University School of Podiatric Medicine (TUSPM) journal review club blog series. In each blog post, a TUSPM student will review a journal article relevant to wound management and related topics and provide their evaluation of the clinical research therein.

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Temple University School of Podiatric Medicine's picture
Wound Care Journal Club Review

Temple University School of Podiatric Medicine Journal Review Club
Editor's note: This post is part of the Temple University School of Podiatric Medicine (TUSPM) journal review club blog series. In each blog post, a TUSPM student will review a journal article relevant to wound management and related topics and provide their evaluation of the clinical research therein.

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By The Alliance of Wound Care Stakeholders

The Alliance of Wound Care Stakeholders Alliance of Wound Care Stakeholders (Alliance) played a key role in educating the Food and Drug Administration (FDA) and its advisory panel on the role and real-world value of antimicrobial wound care dressings, as the FDA considered a regulatory classification of these products that could impact access and availability to wound care providers and patients.

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Thomas Serena's picture
value formula

by Thomas E. Serena MD, FACS, FACHM, FAPWCA

Lawrence Mills introduced the concept of Value Analysis to the manufacturing industry a half century ago. The basic idea entails analyzing the function and importance of the various parts of a product as they relate to cost. He derived the following equation2:

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