Table 2.
Select Examples of FDA OWH-Funded Research and FDA Priorities
| FDA science priority areas of regulatory science | Science funded by the OWH |
|---|---|
| 1. Modernize toxicology to enhance product safety | Developing a knowledge base for better understanding of sex biased drug-induced liver injury31 |
| Identifying a biomarker for trastuzumab-induced cardiotoxicity96 | |
| Increasing the understanding of sex differences in drug toxicity mechanisms at the level of gene expression of drug-metabolizing and transporting enzymes110 | |
| 2. Stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes | Improving the use of biomarkers with comprehensive study of sex differences in F344 rat kidney gene expression111–115 |
| Identifying a gene expression signature for systemic lupus erythematosus116 | |
| Quantifying the variability in interpretation of computer-aided digital microscopy for HER2/neu expression in breast tissue117 | |
| 3. Support new approaches to improve product manufacturing and quality | Using liquid chromatography for simultaneous determination of estradiol, estriol, estrone, and progesterone118 |
| Identifying an approach to improve condom water leak testing119 | |
| 4. Ensure FDA readiness to evaluate innovative emerging technologies | Development of artificial plaques to investigate relationships between composition of plaque and drug transport120 |
| Nanoparticle effects on induction of proinflammatory responses to Candida albicans by cultured vaginal epithelial cells119 | |
| Safety and efficacy of iron oxide nanoparticles used as MRI contrast agents for breast cancer imaging121 | |
| 5. Harness diverse data through information sciences to improve health outcomes | Pilot study testing of a CDISC standard format in vaccine products119 |
| Developing methodology to improve signaling for data mining FDAs Spontaneous | |
| Reports database122 | |
| Combining data from multiple trials submitted to the FDA to identify increased benefit for women using cardiac resynchronization therapy27 | |
| 6. Implement a new prevention-focused food safety system to protect public health | Determining strategies to improve listeriosis prevention messages for pregnant women123 |
| Developing s bioassay to enhance surveillance of gluten-free status in foods81–84 | |
| Supporting the development of CFSAN Women's Health Internet Initiative (Phases I and II)119 | |
| 7. Facilitate development of medical countermeasures to protect against threats to U.S. and Global Health and Security | Investigation of hepatitis B immune globulin administration to pregnant women in animal mode for HBV prophylaxis124 |
| Treatment of progressive vaccinia in a pregnant immunocompromised mouse model119 | |
| Development of a mouse model to mimic the response of female and pregnant human subjects to avian influenza infections and to evaluate the protective efficacy of pandemic H5N1 vaccines against highly pathogenic avian influenza119 | |
| 8. Strengthen social and behavioral science to help consumers and professionals make informed decisions about regulated products | Investigation of gender differences in the willingness to read and follow patient information119 |
| Focus group testing to aid in the development of a uniform contraceptive efficacy table to aid in decision-making119 | |
| Focus group testing of labeling for tampons and barrier contraceptives119 |