FDA Town Hall-New Drug Approvals in Gastrointestinal Disease (2018-2019)

Collaborators, Affiliations

Division of Gastroenterology and Inborn Errors Products, Office of New Drugs, Center for Drug Evaluation and Research:
Juli Tomaino, Suna Seo, Tara Altepeter, Lesley Hanes, Jessica J Lee, Julie Beitz

¹ Georgetown University School of Medicine, Washington, DC; Middleburg Consultants, Takoma Park, Maryland. Electronic address: harris@middleburgconsultants.com.
² University of Tennessee Health Science Center, Memphis, Tennessee.
³ United States Food and Drug Administration, Silver Spring, Maryland.

M Scott Harris et al. Gastroenterology. 2020 Jan.

. 2020 Jan;158(1):18-21.

doi: 10.1053/j.gastro.2019.09.049. Epub 2019 Oct 15.

Division of Gastroenterology and Inborn Errors Products, Office of New Drugs, Center for Drug Evaluation and Research:
Juli Tomaino, Suna Seo, Tara Altepeter, Lesley Hanes, Jessica J Lee, Julie Beitz

¹ Georgetown University School of Medicine, Washington, DC; Middleburg Consultants, Takoma Park, Maryland. Electronic address: harris@middleburgconsultants.com.
² University of Tennessee Health Science Center, Memphis, Tennessee.
³ United States Food and Drug Administration, Silver Spring, Maryland.

No abstract available

Comment in

Looking for Innovative Digital Solutions to Optimize Patient Recruitment in Inflammatory Bowel Disease Trials.
Bouhnik Y, Louis E, Peyrin-Biroulet L. Bouhnik Y, et al. Gastroenterology. 2020 Jun;158(8):2306-2307. doi: 10.1053/j.gastro.2019.11.313. Epub 2020 Mar 19. Gastroenterology. 2020. PMID: 32201177 No abstract available.
Reply.
Harris MS, Wichary J, Zadnik M, Reinisch W. Harris MS, et al. Gastroenterology. 2020 Jun;158(8):2307. doi: 10.1053/j.gastro.2020.03.047. Epub 2020 Mar 29. Gastroenterology. 2020. PMID: 32234535 No abstract available.