FDA-TRACK Update: Expediting the review of biologics through Fast Track Designations

On Track: The FDA-TRACK Monthly Newsletter

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What’s New in August 2016 New performance data are available for the dashboards below. Center for Biologics Evaluation and Research (CBER) CBER Dashboard: The number of fast track designations granted reached an all-time high of 8 in FY16 Q3. In addition, CBER demonstrated a 14% increase in the number of actions taken on original INDs and IDEs in FY16 Q3 (218) compared to the overall average (190.8).                 Center for Tobacco Products (CTP) CTP Dashboard: CTP is investing in a number of public education campaigns to help educate the public—especially youth—about the dangers of regulated tobacco products. Through FY16 Q2, the number of target audience interactions related to CTP’s public education campaigns has eclipsed 20 million. Office of Special Medical Programs (OSMP) OSMP Dashboard: The Office of Pediatric Therapeutics (OPT) provides a Neonatal-Perinatal Medicine consultation service to the Centers that are reviewing development programs for pregnant women, neonates, and young infants. Through FY16 Q2, OPT has provided 12 consultations or reviews through this service. National Center for Toxicological Research (NCTR) NCTR Dashboard: The Division of Genetic and Molecular Toxicology (DGMT) completed its project to develop and validate genetic biomarkers. Its researchers developed and tested a new more simple, accurate, and sensitive genetic analysis approach. This analysis method utilizes next-generation sequencing and publically-available bioinformatics approaches to quickly detect and catalog genetic mutations in cells. An article was published in the March issue of the Environmental Molecular Mutagen Journal. Office of the Commissioner (OC) Office of Operations (OO) Dashboard Office of the Chief Scientist (OCS) Dashboard: The Office of Women’s Health (OWH) selected the new intramural studies for FY16 and issued awards for these studies as part of itsIntramural Research Program Funding Key Project.

September 2016 Upcoming Performance Data Updates

• Center for Drug Evaluation and Research (CDER)
• Center for Food Safety and Applied Nutrition (CFSAN)
• Center for Veterinary Medicine (CVM)
• Office of the Commissioner (OC) Administrative Offices