The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.
The FDA is considering a user-fee program for nonprescription (over-the-counter or OTC) monograph drugs. A user-fee program would provide funding to supplement congressional non-user-fee appropriations and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph. A public meeting on this topic was held on June 10, 2016.
FDA will hold a webinar for stakeholders on Sept 6 from 10:30am-12noon. This webinar is intended to be a followup to the June 10, 2016, public meeting and to provide stakeholders with a status update on the process of FDA and industry discussions that began in July 2016. As a stakeholder, we encourage you or someone from your organization to participate.
Please see the following Federal Register Notice for more details on the webinar and for information on how to register: FR Doc. 2016–11098.