Dusty guidances
This article was originally published in The Tan Sheet
Executive Summary
FDA is withdrawing antidiarrheal, antacid and laxative guidances "because they are out of date and of little use to the drug industry," according to a July 20 Federal Register notice. "The agency has developed other guidances and/or resources to assist the industry in obtaining information on the clinical evaluation and the requirements for approval of these classes of drugs," FDA adds...