Guidance withdrawals
This article was originally published in The Tan Sheet
Executive Summary
FDA is withdrawing guidances on antidiarrheals, antacids and laxatives "because they are out of date and of little use to the drug industry," according to an announcement in the July 20 Federal Register. "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. Information on topics of withdrawn guidances can be obtained from the Division of Gastrointestinal & Coagulation Drug Products in CDER...