FDA News and Recent Committee Actions

Drug Shortages in Clinical Gastroenterology

Radiation and CT Scans

An 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

Multi-Society Position Statement: Nonanesthesiologist Administration of Propofol for GI Endoscopy

A glimpse at the future Food and Drug Administration: A summary of the FDA Amendments Act of 2007
Charles E. Brady M.D., Arthur A. Ciociola, Ph.D. and FDA Related Matters Committee

Tysabri (natalizumab) Injection for IV Use FDA Public Health Advisory and Notification of Product Approval to Companies

Early FDA Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)

Cimzia Notification of Product Approval to Companies