Learn More: OWH’s Encouraging Women to Utilize FDA Safe Medication Use Resources Key Project

As part of the Take Time to Care Program, the Office of Women’s Health (OWH), one of many offices in the Office of the Chief Scientist (OSC), completed the Encouraging Women to Utilize FDA Safe Medication Use Resources Key Project. OWH conducts outreach to diverse populations of women including pregnant women, college women, and minority women. In FY16, OWH disseminated 3.5 million fact sheets, consumer updates, and medication booklets on safe medication use and other FDA regulated products and launched a new Tips for Caregiverswebpage that provides female caregivers with tips and links to FDA resources.

For more information about OWH, please visit the OCS Dashboard and the Take Time to Care Program Key Project for the activities that are planned for FY17.

What’s New in October 2016

New performance data are available for the dashboards below.

Cross Agency

Advisory Committees Dashboard: The FDA advisory committee vacancy rate decreased from 17% in FY16 Q2 to 12% in FY16 Q3.

National Center for Toxicological Research (NCTR)

NCTR Dashboard: The Division of Bioinformatics and Biostatistics (DBB) is now working on its new Sequencing Quality Control Phase II Key Project. The primary objective of this project is to develop standard analysis protocols and quality control metrics for fit-for-purpose use of Next Generation Sequencing (NGS) data to enhance regulatory science research and precision medicine. The project consists of three specific aims to:

1. Develop quality metrics for reproducible NGS results from both whole genome sequencing (WGS) and targeted gene sequencing (TGS);

2. Benchmark bioinformatics methods for WGS and TGS towards the development of standard data analysis protocols; and

3. Assess the joint effects of key parameters affecting NGS results and interpretation for clinical application.

Office of Special Medical Programs (OSMP)

OSMP Dashboard: The Office of Orphan Products Development (OOPD) has added new measures on their Rare Pediatric Disease Priority Review Voucher Program and their Orphan Products Clinical Trials Grants program.

Office of the Commissioner (OC)

OCS Dashboard: The Office of Women’s Health (OWH) completed the Diverse Women in Clinical Trials Awareness Campaign Key Project. OWH collaborated with other FDA partners and organizations to raise awareness about the participation of diverse women in clinical trials. As a result of this project, OWH was able to launch a new Women in Clinical Trials webpage and plans to hold a series of webinars in partnership with the Association of Clinical Research Professionals in November 2016. In addition, the Office of Scientific Professional Development (OSPD) developed milestones for its new 2016 Commissioner’s Fellowship Program Key Project and plans to hire Fellows in FY17 Q2.