FDA and Other Regulatory Agencies Testimony

Our Contributions to the FDA and Other Regulatory Agencies

As part of our continual presence in Washington, DC, and around the United States, whenever appropriate IFFGD offers testimony to the U.S. Food and Drug Administration (FDA) and other regulatory agencies. Through either written or in person statements, we share the perspective of functional GI and motility disorder patients. We urge consideration of the patient perspective in regulatory decisions and encourage additional resources to help meet their needs.

October 25, 2012

IFFGD submitted written testimony in support of irritable bowel syndrome (IBS) to the FDA in response to an October 25, 2012 Prescription Drug User Fee Act Patient-Focused Drug Development Meeting.  Read the full testimony here.

September 12, 2012

IFFGD submitted written testimony to the FDA in connection with an October 16, 2012 meeting of the Gastrointestinal Drugs Advisory Committee to consider the new drug application (NDA) 203441 by NPS Pharmaceuticals for the drug with the proposed trade name GATTEX (teduglutide) for the treatment of adult patients with short bowel syndrome (SBS).  Read the full testimony here.

December 13, 2011

IFFGD submitted written testimony to the FDA in connection with a January 11, 2012 meeting of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee to consider the premarket approval of the LINX Reflux Management System for the treatment of gastroesophageal reflux disease (GERD). Read the full testimony here.

December 2, 2010

IFFGD provided oral testimony to the FDA at a meeting of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee to consider the premarket approval of Solesta from Oceana Therapeutics, Inc. Read the full testimony here.

April 23, 2002

IFFGD presented oral testimony to the FDA at the Gastrointestinal Drugs Advisory Committee regarding risk management for (NDA)21-107, LOTRONEX (alosetron), produced by GlaxoSmithKline. Read the full testimony here.

November 9, 2000

IFFGD sent a letter to the FDA in connection with a November 9, 2000 meeting of the Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee to discuss Lotronex. Read the letter here

June 27, 2000

IFFGD presented oral testimony to the FDA at the Gastrointestinal Drugs Advisory Committee regarding (NDA)21-107, LOTRONEX (alosetron). Read the full testimony here. 

June 26, 2000

IFFGD provided oral testimony to the FDA at the Gastrointestinal Drugs Advisory Committee regarding (NDA) 21-200, Zelnorm/Zelmac (tegaserod), produced by Novartis Pharmaceuticals Corporation. Read the full testimony here.