martes, 6 de septiembre de 2016

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

On Track: The FDA-TRACK Monthly Newsletter

FDA Track
We greatly appreciate the feedback that we have received from the subscriber survey. If you have not yet had a chance to complete it, please take a couple minutes to share your opinions and feedback. Whether it is a topic that you would like us to focus on more or a change in the content layout, we are all ears to learn more about our subscribers and what you want from this newsletter. Thank you!

What’s New in August 2016

New performance data are available for the dashboards below.
Center for Biologics Evaluation and Research (CBER)
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)

September 2016 Upcoming Performance Data Updates

No hay comentarios: