Regulatory advocacy update: American society of plastic surgeons comments in response to the U.S. food and drug administration draft guidance documents on human cell and tissue products

J. Peter Rubin; Richard A. D'Amico; Ricardo Rodriguez; Sydney R. Coleman; Paul Cederna; Scot Glasberg; Michael Neumeister; David H. Song; Charles Butler; Keith M. Hume

doi:10.1097/PRS.0000000000003240

Regulatory advocacy update: American society of plastic surgeons comments in response to the U.S. food and drug administration draft guidance documents on human cell and tissue products

J. Peter Rubin, Richard A. D'Amico, Ricardo Rodriguez, Sydney R. Coleman, Paul Cederna, Scot Glasberg, Michael Neumeister, David H. Song, Charles Butler, Keith M. Hume

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

Abstract

The U.S. Food and Drug Administration released draft guidance documents on human cells, tissues, and cellular and tissue-based products regulations. These proposed guidance documents can impact the practice of plastic surgery in the area of tissue grafting procedures. This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the U.S. Food and Drug Administration by the American Society of Plastic Surgeons.

Original language	English
Pages (from-to)	1259-1261
Number of pages	3
Journal	Plastic and Reconstructive Surgery
Volume	139
Issue number	5
DOIs	https://doi.org/10.1097/PRS.0000000000003240
State	Published - 1 May 2017
Externally published	Yes

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10.1097/PRS.0000000000003240

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Rubin, J. P., D'Amico, R. A., Rodriguez, R., Coleman, S. R., Cederna, P., Glasberg, S., Neumeister, M., Song, D. H., Butler, C., & Hume, K. M. (2017). Regulatory advocacy update: American society of plastic surgeons comments in response to the U.S. food and drug administration draft guidance documents on human cell and tissue products. Plastic and Reconstructive Surgery, 139(5), 1259-1261. https://doi.org/10.1097/PRS.0000000000003240

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title = "Regulatory advocacy update: American society of plastic surgeons comments in response to the U.S. food and drug administration draft guidance documents on human cell and tissue products",

abstract = "The U.S. Food and Drug Administration released draft guidance documents on human cells, tissues, and cellular and tissue-based products regulations. These proposed guidance documents can impact the practice of plastic surgery in the area of tissue grafting procedures. This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the U.S. Food and Drug Administration by the American Society of Plastic Surgeons.",

author = "Rubin, {J. Peter} and D'Amico, {Richard A.} and Ricardo Rodriguez and Coleman, {Sydney R.} and Paul Cederna and Scot Glasberg and Michael Neumeister and Song, {David H.} and Charles Butler and Hume, {Keith M.}",

note = "Publisher Copyright: Copyright {\textcopyright} 2017 by the American Society of Plastic Surgeons.",

year = "2017",

month = may,

day = "1",

doi = "10.1097/PRS.0000000000003240",

language = "English",

volume = "139",

pages = "1259--1261",

journal = "Plastic and Reconstructive Surgery",

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publisher = "Lippincott Williams and Wilkins Ltd.",

number = "5",

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Rubin, JP, D'Amico, RA, Rodriguez, R, Coleman, SR, Cederna, P, Glasberg, S, Neumeister, M, Song, DH, Butler, C & Hume, KM 2017, 'Regulatory advocacy update: American society of plastic surgeons comments in response to the U.S. food and drug administration draft guidance documents on human cell and tissue products', Plastic and Reconstructive Surgery, vol. 139, no. 5, pp. 1259-1261. https://doi.org/10.1097/PRS.0000000000003240

Regulatory advocacy update: American society of plastic surgeons comments in response to the U.S. food and drug administration draft guidance documents on human cell and tissue products. / Rubin, J. Peter; D'Amico, Richard A.; Rodriguez, Ricardo et al.
In: Plastic and Reconstructive Surgery, Vol. 139, No. 5, 01.05.2017, p. 1259-1261.

Research output: Contribution to journal › Article › peer-review

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AU - Rodriguez, Ricardo

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AU - Cederna, Paul

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AU - Hume, Keith M.

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AB - The U.S. Food and Drug Administration released draft guidance documents on human cells, tissues, and cellular and tissue-based products regulations. These proposed guidance documents can impact the practice of plastic surgery in the area of tissue grafting procedures. This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the U.S. Food and Drug Administration by the American Society of Plastic Surgeons.

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ER -

Regulatory advocacy update: American society of plastic surgeons comments in response to the U.S. food and drug administration draft guidance documents on human cell and tissue products

Abstract

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