Gastroenterology Endpoints To Get Four-Day Series Of FDA Workshops
This article was originally published in The Pink Sheet Daily
One day each will be devoted to eosinophilic esophagitis, pediatric and adult inflammatory bowel disease, and parenteral nutrition-associated liver disease, Sept. 19, 20, 21 and 24, in that order.
You may also be interested in...
FDA is holding another workshop to discuss selection of endpoints in development of drugs to treat pediatric and adult inflammatory bowel diseases; the agency held four gastroenterology workshops last year.
Patient groups urge FDA not to limit 20 meetings over the next five years to specific diseases, as the agency has proposed, but instead to take a broader view on diseases based upon similar characteristics, quality-of-life burden and available treatment options.
The agency is holding a public workshop to discuss therapeutic targets and clinical trial design for disease-modifying agents to treat peripheral neuropathy; many products in recent development have faced challenges.