Perinatal (i.e., the periods of time including pregnancy, childbirth, and infant/child development) and maternal health have been cornerstones of NCTR regulatory science research for over 40 years.
Many drugs and other medical products provided to pregnant women, neonates, and infants are used off-label due to ethical concerns performing clinical trials in these understudied populations. In addition, environmental exposure through foods represents another knowledge gap; infants consume more food per kilogram of body weight than any other age group, which could result in higher dietary exposures to chemicals. Often there is little to no available data to assess potential risks with these exposures; thus, safety and risk assessments for foodborne chemicals, biological-, and/or chemical-threat agents rely upon data obtained from animal models and in vitro cellular toxicology studies.
Congress directed NCTR to lead efforts to create and manage the FDA virtual Perinatal Health Center of Excellence (PHCE). The PHCE was established in 2018 as an FDA-wide collaborative effort to review and fund research related to perinatal populations on an annual basis.
With the support of collaborating product centers, NCTR coordinates the activities of the PHCE to conduct studies that address important perinatal regulatory-science needs. PHCE-funded research falls into the following categories: new alternative models, traditional toxicology studies, translational and clinical studies, computational modeling, bioanalytical chemistry, exposure science, and bioinformatics targeting. The highest priority during the selection process is given to projects with a potential for wide regulatory impact, including policy changes and realigning industry standards, thereby improving clinical practice and research approaches.