Recent ACG FDA Committee Actions

Biosimilars in IBD: Slides from the 2017 ACG Workshop with the FDA and EMA
ACG’s FDA Related Matters Committee hosted a public workshop with the FDA and the European Medicines Agency (EMA) and addressed the question of the practical implications for GI clinicians prescribing IBD medications at the WCOG at ACG 2017.  The workshop compared the approval processes of biosimilar drugs in both agencies, with a focus on IBD.  The EMA provided some insight from their history of approving biosimilar drugs in IBD.  The FDA also provided some practical tips for ACG members and GI clinicians.

Biosimilars: The Need, The Challenge, The Future: The FDA Perspective (December 2014)

2014 American College of Gastroenterology (ACG) and U.S. Food & Drug Administration (FDA) Public Forum: Toward Improving the Quality of Colonoscopy and Evidenced-Based Bowel Preparation
On Monday, October 20th, ACG and the FDA held a workshop at the 2014 ACG Annual Scientific Meeting on clinical endpoints in bowel preparation products.

ACG workshop with the FDA to review the efficacy in treating symptoms, the role of endoscopy, as well as managing eosinophils count
On October 22, 2012 the ACG FDA Related Matters Committee hosted a public workshop entitled Eosinophilic esophagitis (EoE): What are clinical endpoints for treatment and drug studies?

How the FDA Manages Drug Safety With Black Box Warnings, Use Restrictions, and Drug Removal, With Attention to Gastrointestinal Medications

“Feasibility of Mucosal Healing as a Clinically Significant Endpoint in Inflammatory Bowel Disease Clinical Trials”
American College of Gastroenterology and the U.S. Food & Drug Administration Joint Workshop

The FDA’s Generic-Drug Approval Process: Similarities to and Differences From Brand-Name Drugs

Drug Shortages in Clinical Gastroenterology

  • ACG FDA Related Matters Committee Hosts Webinar on Drug Shortages in Gastroenterology

Radiation and CT Scans