FDA RELATED MATTERS COMMITTEE MEMBERS Eric D. Shah, MD, MBA, FACG, Chair George G. Abdelsayed, MD, FACG Dawn M. Beaulieu, MD Kendall R. Beck, MD Kalyan R. Bhamidimarri, MD, MPH, FACG Shrinivas Bishu, MD James B. Canavan, MD, PhD Amanda K. Cartee, MD Saurabh Chawla, MD, FACG Jacqueline N. Chu, MD H. Matthew Cohn, MD
Parakkal Deepak, MD, FACG Linda A. Feagins, MD, FACG Martin I. Golding, MD, FACG Lawrence Goldkind, MD Paul Guarino, MD, FACG Stephen Hasak, MD Yasmin G. Hernandez-Barco, MD Justin T. Kupec, MD, FACG Vladimir M. Kushnir, MD Benjamin H. Levy, III, MD Jasbir S. Makker, MD, FACG
Suresh Kumar Nayudu, MD, FACG Young Oh, MD, MS Harini Rathinamanickam, MD Fayez S. Sarkis, MD Jason N. Schairer, MD Adam F. Steinlauf, MD Eric J. Vargas, MD Shivakumar Vignesh, MD, FACG
Eric D. Shah, MD, MBA, FACG
RESPONSIBILITIES AS STATED IN THE ACG BYLAWS
COMMITTEE REPORT
This Committee shall be responsible for maintaining and strengthening the College’s relationship with the Food and Drug Administration (FDA), as well as providing topical information to The American Journal of Gastroenterology and other ACG publications and meetings regarding GI drugs and devices that have been reviewed and/or approved by the FDA.
The ACG-FDA Fellowship Program Due to COVID-19, the ACG-FDA fellowship program was put on hold. The Committee hopes to resume the application process in the summer of 2021.
OBJECTIVES 1. Maintain and enhance an ongoing relationship with the U.S. Food and Drug Administration (FDA):
In October 2012, the ACG Board of Trustees approved the creation of the ACG-FDA GI Fellows Program. The program provides funding to support up to two fellows to participate each year along with a stipend to attend the ACG Annual Meeting to present and discuss the fellow's experiences. The Committee annually reviews applications and selects candidates for this ACG-FDA Fellowship Program.
• To assess impact of FDA decisions regarding drugs/devices and to inform ACG leadership and members.
The fellow(s) will subsequently become a member of the FDA Related Matters Committee.
• To provide suggestions for the FDA GI Drug Advisory Committee. • To develop and maintain collaborative programs with the FDA. 2. Provide updates, via The American Journal of Gastroenterology, SmartBrief, the ACG website, other media, and workshops or symposia, for our members on key issues stemming from FDA policies or decisions.
FDA Network of Experts The College is also a member-organization of the FDA’s “Network of Experts.” This program is a vetted network of partner organizations and their member scientists, clinicians and engineers who can provide the FDA rapid access to expertise when it is needed to supplement existing knowledge and expertise within the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER).
3. Serve as a resource for members to report adverse events (AEs) more easily. The FDA Related Matters Committee in 2021 is under the leadership of Chair Eric Shah, MD, MBA, FACG.
2020–2021 ACG AWARDS & LEADERSHIP | 63
ACG LEADERSHIP
• To serve in an advisory role concerning gastroenterology products.
