Learn More: PrecisionFDA

PrecisionFDA was created by the FDA’s Office of Health Informatics (OHI) under FDA’s Chief Health Informatics Officer, Taha Kass-Hout, MD, MS, and OHI’s Deputy Director, Elaine Johanson, and is being developed under a contract with DNANexus. The goal of precisionFDA is to help advance the regulatory science needed to assess the accuracy of genome testing and software. PrecisionFDA launched successfully in beta on December 15, 2015. It is one of the first deliverables to emerge from the President’s Precision Medicine Initiative. It is an online, cloud-based portal that allows scientists from industry, academia, government and standards-setting organizations to come together in a ‘community’ to work on perfecting the science and to foster the innovation behind a method of “reading” DNA known as next-generation sequencing (or NGS). The precisionFDA team has engaged a cadre of twenty two diverse external stakeholder organizations. To-date, these organizations have provided FDA with requirements, tools, and reference materials (e.g., data, workflows). At the time of launch, there were over 200 Community Members, 8 reference apps, 39 reference files, a comparator tool for comparing two sets of variants (VCF files) and a FASTQ simulator. For feature descriptions, terminology and other information, visit the precisionFDA guide. As of February 2016, precisionFDA has over 1,000 users from approximately 500 different organizations. On February 25, 2016, the White House held a Precision Medicine Initiative (PMI) Summit, where the President discussed precisionFDA and the FDA formally launched the first precisionFDA community challenge. This challenge calls on members of the genomics community to assess their bioinformatics software on supplied reference human datasets. To track progress on this initiative, visit FDA-TRACK PrecisionFDA.

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FY15 Web Results: Visit this page for annual web results, including the top program areas, measures and projects viewed in FY15, and the number of subscribers signed up to receive FDA-TRACK monthly email updates.

What’s New in February 2016

Touted by the Alliance for a Stronger FDA, FDA-TRACK is an effort to demonstrate accountability to our stakeholders and provides progress on key actives measured across the agency. Be sure to visitFDA-TRACK to see how we’re doing!

New performance data are available for the dashboards below.

Cross Agency

Advisory Committees Dashboard: At the end of FY15, the advisory committees vacancy ratewas 11%, 1% short of the agency’s target of 10%. Additionally, only 1 out of the 926 advisory committee members who participated in an advisory committee meeting in FY15 received aconflict of interest waiver.

Unified Agenda-TRACK: The Fall 2015 Unified Agenda has been published; check out what rules and regulations FDA is working on here!

Office of Special Medical Programs (OSMP)

OSMP Dashboard: In FY15, OSMP completed 589 orphan drug application reviews, a 23% increase from FY14’s record high number of 480. Despite the higher workload in FY15, the Office was able to review 92% of the orphan drug applications in the 90 day time frame.

National Center for Toxicological Research (NCTR)

NCTR Dashboard: NCTR added new milestones to the Bisphenol A (BPA) Data Gap Analysisproject. The project evaluates the toxicities associated with exposure to BPA, a component in baby bottles and formula and food/water containers, to determine the appropriate safety levels for humans.

Office of the Commissioner (OC)

Office of the Chief Scientist (OCS) Dashboard: The Office of Women’s Health (OWH) is tracking two new projects. The Diverse Women in Clinical Trials Awareness Campaign aims to raise awareness of the importance of the participation of diverse women in clinical trials by conducting digital and traditional outreach activities. The OWH Intramural Research Programawards research grants for studies addressing health conditions and diseases that solely or disproportionately affect women, and the identification and understanding of sex differences related to the safety or efficacy of FDA-regulated products.

March 2016 Upcoming Performance Data Updates