ACG-FDA Visiting Fellowship Program: Dr. Kendall Beck’s Experience at the FDA

In October of 2016, Kendall Beck completed a one month rotation with the FDA’s Gastroenterology and Inborn Errors Products (DGIEP) division through ACG’s Visiting Fellowship Program.  Dr. Beck, a third year fellow at the University of California, ...

Recent FDA Safety Alerts Impacting GI

On Tuesday, June 7th, the FDA warned the public about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium): taking higher than recommended doses of both the non-prescription, over-the-counter (OTC) and prescription ...

FDA Updates Guidance: How to Request Domperidone for GI Disorders

ACG continues to work with the FDA in helping members obtain access to domperidone for patients.  As you know, domperidone is not currently a legally marketed human drug and it is not approved for sale in the U.S. On June 7, 2004, FDA issued ...

FDA’s New Online Education on Biosimilars

New FDA Overview of Biosimilar Products The U.S. Food and Drug Administration on Frebruary 18, 2016 released an online CDERLearn continuing education credit course for health care professionals about biosimilars: “FDA Overview of Biosimilar ...

FDA updates automated endoscope reprocessor information

The FDA has released updated information on automated endoscope reprocessors identifying which manufacturers have completed Automated Endoscope Reprocessors (AER) validation testing with adequate results. AERs are important devices widely used ...

Senate Committee Weighs-in on FDA Review of Duodendscopes

Whitfield L. Knapple, MD, FACGChair, ACG National Affairs On Wednesday, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member, Sen. Patty Murray (D-WA) released a new report: “Preventable Tragedies: Superbugs and How ...