22 de maio de 2019

FDA-TRACK: What's New

From: www.fda.gov

To facilitate a better understanding of the many ways the U.S. Food and Drug Administration (FDA) helps to ensure drugs are safe and effective for the American public, today the FDA’s Center for Drug Evaluation and Research (CDER) launched a redesigned CDER FDA-TRACK webpage with seven new dashboards. The CDER FDA-TRACK webpage is part of FDA-TRACK, launched in 2010 as one of many ways the FDA seeks to ensure transparency. FDA-TRACK is the FDA's agency-wide performance management system that monitors FDA programs through key performance measures and projects.

This new CDER FDA-TRACK webpage highlights a wide range of CDER-specific measures. Some are well-known, for instance how many New Drug Applications (NDAs), Biologics License Applications (BLAs), or First Generic applications have been recently approved. However, there are many other measures of CDER’s work that may be less well-known. For instance, the dashboard shows that each month CDER’s physicians, statisticians, researchers, and many other subject matter experts typically deliver more than 100 scientific presentations at meetings and conferences, both nationally and globally. 

Additionally, each month, CDER scientists publish dozens of journal articles, editorials, regulatory publications, and other communications that help advance the science of innovative drug safety and development.

While CDER’s new FDA-TRACK dashboards offer stakeholders many valuable FDA-related measures, there remain limitations to the data. For example, the site is thorough but not comprehensive; there is a lot of other work that CDER does that is not quantified on the site. Additionally, the numbers provided are meant to help the public better understand the scope of what CDER does --- but importantly, observed increases and decreases in these measures should not be seen as improvements or deficiencies.

For more information about the newly redesigned CDER FDA-TRACK webpage, please see the latest FDA-TRACK newsletter.