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Sp1174
FDA REVIEW OF REBYOTA FOR RECURRENT C. DIFFICILE INFECTION
Date
May 9, 2023
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This session was jointly developed by AGA and representatives from the Division of Gastroenterology at the FDA Center for Drug Evaluation and Research. This session will give health care professionals and clinical trialists a chance to hear directly from FDA representatives about the agency's thinking behind the most recent product approvals and guidance documents impacting the GI community. The 2023 session will address new therapies for IBD, EoE, and C. difficile infection, as well as the agency's current thinking on artificial intelligence-enabled medical devices.
Switching from originator to biosimilar infliximab (IFX) is effective and safe. However, data on multiple switching are scarce. The Edinburgh IBD unit has undertaken three switch programmes: (1) Remicade to CT-P13 (2016), (2) CT-P13 to SB2 (2020), and (3) SB2 to CT-P13 (2021)…
Switching from originator to biosimilar infliximab (IFX) is effective and safe. However, data on multiple switching are scarce. The Edinburgh IBD unit has undertaken three switch programmes: (1) Remicade to CT-P13 (2016), (2) CT-P13 to SB2 (2020), and (3) SB2 to CT-P13 (2021)…
Switching from originator to biosimilar infliximab (IFX) is effective and safe. However, data on multiple switching are scarce. The Edinburgh IBD unit has undertaken three switch programmes: (1) Remicade to CT-P13 (2016), (2) CT-P13 to SB2 (2020), and (3) SB2 to CT-P13 (2021)…