FDA Draft Guidance for Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet: Comments by the Society for the Study of Celiac Disease

SSCD Executive Council; SSCD Writing Committee

doi:10.1053/j.gastro.2022.07.024

FDA Draft Guidance for Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet: Comments by the Society for the Study of Celiac Disease

SSCD Executive Council, SSCD Writing Committee

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

Original language	English (US)
Pages (from-to)	495-496
Number of pages	2
Journal	Gastroenterology
Volume	164
Issue number	3
DOIs	https://doi.org/10.1053/j.gastro.2022.07.024
State	Published - Mar 2023

ASJC Scopus subject areas

Hepatology
Gastroenterology

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10.1053/j.gastro.2022.07.024

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@article{7217077c642c4440a96ae4bfbad28a37,

title = "FDA Draft Guidance for Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet: Comments by the Society for the Study of Celiac Disease",

author = "{SSCD Executive Council} and {SSCD Writing Committee} and Benjamin Lebwohl and Ritu Verma and Ciaran Kelly and Daniel Leffler and Vanessa Weisbrod and {Roland Lee}, Anne and Maureen Leonard and Amelie Therrien and Daniel Adelman and Marilyn Geller and Joseph Murray",

note = "Funding Information: Conflicts of interest These authors disclose the following: Dr Adelman has served as a consultant or advisor to Takeda, GSK, Anokion, Equillium, and Protagonist. Ms Geller served as a consultant for ICON. Dr Kelly has served as a consultant or advisor to Cour Pharma, Jansen (J&J), Kanyos/Anokion, Merck, Milky Way Life Sciences, Takeda, and Teravance; as an Investigator to Merck, Milky Way Life Sciences, and Takeda; and holds stock options in Cour Pharma and Glutenostix. Dr Leonard has served as a consultant to Mozart Therapeutics and Amgen Pharmaceuticals; as an advisory board member for 9 Meters Biopharma; and received research support from Glutenostics LLC. Dr Leffler is an employee of Takeda Pharmaceutical. Dr Murray reports grants from Nexpep/ImmusanT, Immunogenix, Takeda Pharmaceutical, Allakos, Provention Bio, Oberkotter Foundation, and Kanyos/Anokion; and consultancy fees from Johnson & Johnson, Bristol Myers Squibb, Intrexon Corporation, Dren Bio, Neoleukin, Reistone Pharma, Immunic Therapeutics, Senda Biosciences, Brightseed Bio, Chugai Pharma, Kanyos, Alimentiv, Equillium, Ukko, and Vial Health Technologies; and has received royalties from Torax Medical and Evelo. The remaining authors disclose no conflicts. ",

year = "2023",

month = mar,

doi = "10.1053/j.gastro.2022.07.024",

language = "English (US)",

volume = "164",

pages = "495--496",

journal = "Gastroenterology",

issn = "0016-5085",

publisher = "W.B. Saunders Ltd",

number = "3",

}

TY - JOUR

T1 - FDA Draft Guidance for Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet

T2 - Comments by the Society for the Study of Celiac Disease

AU - SSCD Executive Council

AU - SSCD Writing Committee

AU - Lebwohl, Benjamin

AU - Verma, Ritu

AU - Kelly, Ciaran

AU - Leffler, Daniel

AU - Weisbrod, Vanessa

AU - Roland Lee, Anne

AU - Leonard, Maureen

AU - Therrien, Amelie

AU - Adelman, Daniel

AU - Geller, Marilyn

AU - Murray, Joseph

N1 - Funding Information: Conflicts of interest These authors disclose the following: Dr Adelman has served as a consultant or advisor to Takeda, GSK, Anokion, Equillium, and Protagonist. Ms Geller served as a consultant for ICON. Dr Kelly has served as a consultant or advisor to Cour Pharma, Jansen (J&J), Kanyos/Anokion, Merck, Milky Way Life Sciences, Takeda, and Teravance; as an Investigator to Merck, Milky Way Life Sciences, and Takeda; and holds stock options in Cour Pharma and Glutenostix. Dr Leonard has served as a consultant to Mozart Therapeutics and Amgen Pharmaceuticals; as an advisory board member for 9 Meters Biopharma; and received research support from Glutenostics LLC. Dr Leffler is an employee of Takeda Pharmaceutical. Dr Murray reports grants from Nexpep/ImmusanT, Immunogenix, Takeda Pharmaceutical, Allakos, Provention Bio, Oberkotter Foundation, and Kanyos/Anokion; and consultancy fees from Johnson & Johnson, Bristol Myers Squibb, Intrexon Corporation, Dren Bio, Neoleukin, Reistone Pharma, Immunic Therapeutics, Senda Biosciences, Brightseed Bio, Chugai Pharma, Kanyos, Alimentiv, Equillium, Ukko, and Vial Health Technologies; and has received royalties from Torax Medical and Evelo. The remaining authors disclose no conflicts.

PY - 2023/3

Y1 - 2023/3

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DO - 10.1053/j.gastro.2022.07.024

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AN - SCOPUS:85147983837

SN - 0016-5085

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SP - 495

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JF - Gastroenterology

IS - 3

ER -

FDA Draft Guidance for Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet: Comments by the Society for the Study of Celiac Disease

ASJC Scopus subject areas

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