FDA Information

Recent ACG FDA Committee Actions

• New! AJG Red Section Article: Overview of Biosimilars in Inflammatory Bowel Diseases
• Clinical & Translational Gastroenterology Editorial: Microbiome-Based Therapeutics in Digestive Diseases: What They Are and How Are They Regulated
• ACG Magazine Spring ’23 Article: Getting it Right: How FDA Drug and Biologic Therapy Labels Are Developed and How to Optimize Their Use in Clinical Practice
• FDA Advisory Committees: Its Role and How To Contribute
• Accessing Food and Drug Administration resources in clinical practice: A primer for the practicing gastroenterologist

  The inner workings of the Food and Drug Administration (FDA) can seem elusive from the realities of the day-to-day clinical practice. For the FDA to accomplish its mission, they have exclusive access to comprehensive and historical clinical trial data and a wealth of outcomes data. These data include the largest claims dataset covering over 227 million Americans, including patient-level data (2). Staying up-to-date with FDA communications is important as gastroenterologists and their patients look for guidance in areas of rapid innovation such as biosimilars(3), fecal microbiota for transplantation(4), and endoscopic bariatric treatments.

  Click here for a summary of useful datasets and resources published on the FDA website which can enable gastroenterologists to stay current with regulatory guidance and access valuable FDA resources.

  
  

Important Resources From the FDA

• FDA
• FDA Approved Drug Products
• Guidances (Drugs)
• FDA MedWatch: Report an Adverse Event to FDA (form FDA 3500)
• Recalls, Market Withdrawals & Safety Alerts
• Index to Specific Drug Information
• Fecal Microbiota Products and FMT
• Accessing Domperidone:
• Information about Domperidone
• How to Request Domperidone for Expanded Access Use