Programs

To tackle the human health challenges that face the world today, the FNIH develops collaborations with top experts from government, industry, academia and the not-for-profit sector and provides a neutral environment where we can work productively toward a common goal.

Multi-site Efficacy and Safety Trial of Intrapartum Azithromycin in Low- and Middle-Income Countries

This study will test whether an antibiotic taken during labor can prevent infections in mothers and newborns in seven low- and middle-income countries. It will be conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) through their Global Network for Women’s and Children’s Health Research (Global Network) in partnership with the Bill & Melinda Gates Foundation.

Biomarkers Consortium - Workshop: Defining an Evidentiary Criteria Framework for Surrogate Endpoint Qualification

The FNIH Biomarkers Consortium and FDA hosted a workshop to provide a Framework for Defining the Evidentiary Criteria for Surrogate Endpoint Qualification on July 30-31, 2018. The workshop aimed to create alignment of the biomedical community and regulators on the levels of evidence required to qualify biomarkers for use in drug development, with an emphasis on surrogate endpoints and specific clinical outcome measures.