FDA Stakeholder Update - November 26, 2019

Public Meetings, Workshops and Webinars

Regulatory Education for Industry (REdI): 2019 CDER Prescription Drug Labeling Conference Date: December 4, 2019 to December 5, 2019 Time: 8:00 a.m. to 5:00 p.m. ET Agenda: The goal of this interactive conference is to provide useful information on prescription drug labeling development and discuss recently published FDA labeling guidances. FDA labeling specialists will present their unique perspectives concerning approaches and challenges in developing the Prescribing Information, FDA-approved patient labeling, and carton/container labeling, and will discuss methods to improve the quality of Structured Product Labeling (SPL) submissions. Repurposing Off-Patent Drugs: Research & Regulatory Challenges Date: December 5, 2019 to December 6, 2019 Time: 7:30 a.m. to 5:00 p.m. ET Agenda: This workshop will explore opportunities and challenges in assessing the safety and efficacy of repurposed drugs; patient experiences; and potential strategies to prioritize certain drugs and diseases for repurposing. The meeting will feature interactive sessions aimed at finding possible solutions to obstacles in drug repurposing. It will also highlight FDA and NIH activities that support repurposing.