Gastroenterology group asks FDA for more discussion on GERD guidances (Regulatory Affairs Professionals Society)

The American College of Gastroenterology (ACG) has urged the US Food and Drug Administration (FDA) to consider certain inclusion and exclusion criteria when asking sponsors to conduct clinical trials for drugs to treat gastroesophageal reflux disease (GERD). The group commented on two draft guidances on the topic and asked the agency to convene public meetings to allow more dialogue before the guidances are finalized.