U.S. flag An official website of the United States government
  1. Home
  2. For Consumers
  3. Women's Health
  4. Women's Health Research
  5. OWH-Funded Research
  6. Project Areas by Topic
  1. OWH-Funded Research

Project Areas by Topic

From the FDA Office of Women's Health

Image
Image of health care providers

On this page: Searchable table | Related links 

The FDA Office of Women’s Health (OWH) awards research grants for studies to support FDA regulatory decision-making, to evaluate the impact of sex differences on product safety and efficacy, and to advance the science of women’s health. 

The research conducted by OWH-funded investigators helps inform safety, efficacy, quality, and performance of the products FDA regulates. Research conducted by FDA scientists and external investigators also contributes to advances in science and technology in general and promotes innovation in medical product development and food and cosmetic safety.

OWH has funded research projects that address health topics affecting women including cardiovascular disease, bioinformatics, cancer, device safety, pregnancy/reproductive health, sex differences, and women in clinical trials.

Intramural, Extramural and Special Funding Research Initiatives by Funding Year, and Research Area

Year Program PI Center/Organization Project Title Research Areas OWH Focus
2024 Intramural CAMACHO, LUISA NCTR Systematic evaluation of reconstructed human skin models to predict the percutaneous absorption of cosmetic ingredients and other FDA-regulated products Cosmetics Predominantly affects women
2024 Intramural CAMACHO, LUISA NCTR Systematic evaluation of reconstructed human skin models to predict the percutaneous absorption of cosmetic ingredients and other FDA-regulated products Dermatology  
2024 Intramural WILLETT, ROSE NCTR Sex-comparative cancer modeling: Determining the sex differences in lorcaserin-induced non-genotoxic mechanisms associated with increased female lung cancer prevalence Oncology/cancer Sex differences
2024 Intramural WILLETT, ROSE NCTR Sex-comparative cancer modeling: Determining the sex differences in lorcaserin-induced non-genotoxic mechanisms associated with increased female lung cancer prevalence Biomarkers  
2024 Intramural YU, LI-RONG NCTR Informed prediction of anthracycline-induced cardiotoxicity (IMPACT): A multicenter biomarker qualification study Oncology/cancer Only women
2024 Intramural YU, LI-RONG NCTR Informed prediction of anthracycline-induced cardiotoxicity (IMPACT): A multicenter biomarker qualification study Toxicology  
2024 Intramural YU, LI-RONG NCTR Informed prediction of anthracycline-induced cardiotoxicity (IMPACT): A multicenter biomarker qualification study Biomarkers  
2024 Intramural GUO, WENJING NCTR Identify sex disparities in opioid drug safety signals in FDA adverse events report system (FAERS) and social media Twitter to improve women's health Pharmaceuticals Sex differences
2024 Intramural GUO, WENJING NCTR Identify sex disparities in opioid drug safety signals in FDA adverse events report system (FAERS) and social media Twitter to improve women's health Opioids  
2024 Intramural FAIRMAN, KIARA NCTR Pregnancy Pharmacokinetic Database Obstetrics/Gynecology Only women
2024 Intramural FAIRMAN, KIARA NCTR Pregnancy Pharmacokinetic Database Pharmacology  
2024 Intramural MAZOR, RONIT CBER Investigation of sex difference in immunogenicity and efficacy of AAV mediated gene therapy Immunology Sex differences
2024 Intramural MAZOR, RONIT CBER Investigation of sex difference in immunogenicity and efficacy of AAV mediated gene therapy Gene therapy  
2023 Intramural AYYOUB, AMAL CDER Evaluation of the Impact of Dose Interruptions and Reductions on the Clinical Efficacy of Targeted Breast Cancer Drugs Oncology/cancer Predominantly affects women
2023 Intramural AYYOUB, AMAL CDER Evaluation of the Impact of Dose Interruptions and Reductions on the Clinical Efficacy of Targeted Breast Cancer Drugs Pharmacology  
2023 Intramural WU, WEN JIN CDER Identify therapeutic biomarkers, characterize bispecific antibodies (BsAbs) to treat ovarian cancer (OC), and support the reviews of FDA-regulated BsAbs Oncology/cancer Only women
2023 Intramural WU, WEN JIN CDER Identify therapeutic biomarkers, characterize bispecific antibodies (BsAbs) to treat ovarian cancer (OC), and support the reviews of FDA-regulated BsAbs Biologics  
2023 Intramural PINTO, CAROLINE CDRH Application of in vitro and in silico models to predict the total estrogenicity of chemicals released from cardiovascular medical devices Oncology/cancer Predominantly affects women
2023 Intramural PINTO, CAROLINE CDRH Application of in vitro and in silico models to predict the total estrogenicity of chemicals released from cardiovascular medical devices Medical device  
2023 Intramural SAMALA, RAVI CDRH Tackling sex bias in AI for severity assessment of COVID-19 Infectious diseases Sex differences
2023 Intramural SAMALA, RAVI CDRH Tackling sex bias in AI for severity assessment of COVID-19 Medical device  
2023 Intramural SAMALA, RAVI CDRH Tackling sex bias in AI for severity assessment of COVID-19 Artificial Intelligence  
2023 Intramural CAI, CHENGZHONG NCTR Potential Context of Use for a Human-Based Engineered Heart Tissue System to Detect Sex Disparities of Chemotherapy Drugs  (Special Funding) Oncology/cancer Sex differences
2023 Intramural CAI, CHENGZHONG NCTR Potential Context of Use for a Human-Based Engineered Heart Tissue System to Detect Sex Disparities of Chemotherapy Drugs  (Special Funding) Pharmaceuticals  
2023 Intramural CHEN, MINJUN NCTR Identify genetic and nongenetic factors with increasing susceptibility to herbal dietary supplement (HDS)-induced liver injury in women Dietary supplements Sex differences
2023 Intramural CHEN, MINJUN NCTR Identify genetic and nongenetic factors with increasing susceptibility to herbal dietary supplement (HDS)-induced liver injury in women Pharmacogenomics  
2023 Intramural CHEN, MINJUN NCTR Identify genetic and nongenetic factors with increasing susceptibility to herbal dietary supplement (HDS)-induced liver injury in women Toxicology  
2023 Intramural LI, DONGYING NCTR Sex-biased safety profiles in IND submissions and its manifestation in NDA approval and post-marketing surveillance  Pharmaceuticals Sex differences
2022 Intramural XIE, HANG CBER Investigating the impact of SARS-CoV-2 infection on female fertility and assessing vaccination-induced immunity in protecting pregnant K18-ACE2 transgenic mice against emerging SARS-CoV-2 variants Infectious diseases Only women
2022 Extramural SON, MOEUN Yale-Mayo Evaluate the application of machine learning algorithms to the management of postpartum hemorrhage Obstetrics/Gynecology Only women
2022 Extramural SHAH, SAMIT Yale-Mayo Improving the Diagnosis and Treatment of Women with Myocardial Ischemia and No Obstructive Coronary Artery Disease Cardiovascular Only women
2022 Extramural STINCHCOMB, AUDRA University of Maryland Evaluating Quality Performance of Extemporaneously Compounded Estrogen Hormone Products Obstetrics/Gynecology Only women
2022 Extramural STINCHCOMB, AUDRA University of Maryland Evaluating Quality Performance of Extemporaneously Compounded Estrogen Hormone Products Pharmacology  
2022 Extramural STINCHCOMB, AUDRA University of Maryland Evaluating Quality Performance of Extemporaneously Compounded Estrogen Hormone Products Pharmaceuticals  
2021 Intramural KAMAL, NAHID CDER Affordable generics for menopausal women: Mechanistic evaluation of forumulation design and performance of estradiol intravaginal ring products Obstetrics/Gynecology  
2021 Intramural KAMAL, NAHID CDER Affordable generics for menopausal women: Mechanistic evaluation of forumulation design and performance of estradiol intravaginal ring products Medical device  
2021 Intramural TOLNAY, MATE CDER Define a biomarker of decidual inflammation to predict recurrent pregnancy loss Obstetrics/Gynecology Only women
2021 Intramural TOLNAY, MATE CDER Define a biomarker of decidual inflammation to predict recurrent pregnancy loss Immunology  
2021 Intramural TOLNAY, MATE CDER Define a biomarker of decidual inflammation to predict recurrent pregnancy loss Biomarkers  
2021 Intramural ZIDAN, AHMED CDER Developing quality standards for an innovative personalized 3D printed intravaginal ring for menopausal women Obstetrics/Gynecology Only women
2021 Intramural ZIDAN, AHMED CDER Developing quality standards for an innovative personalized 3D printed intravaginal ring for menopausal women Medical device  
2021 Extramural IWASAKI, AKIKO Yale-Mayo Sex differences in immune profiles of PASC before and after vaccination  Infectious diseases Sex differences
2021 Extramural IWASAKI, AKIKO Yale-Mayo Sex differences in immune profiles of PASC before and after vaccination  Immunology  
2021 Intramural BIGHAMIAN, RAMIN CDRH Next generation sex-specific ventilator systems enabled by neural activity Pulmonary Sex differences
2021 Intramural BIGHAMIAN, RAMIN CDRH Next generation sex-specific ventilator systems enabled by neural activity Medical device  
2021 Extramural KLEIN, SABRA Johns Hopkins Defining SARS-CoV2 vaccine-induced immunity in pregnant and lactating people Infectious diseases Only women
2021 Extramural KLEIN, SABRA Johns Hopkins Defining SARS-CoV2 vaccine-induced immunity in pregnant and lactating people Immunology  
2021 Extramural KLEIN, SABRA Johns Hopkins Defining SARS-CoV2 vaccine-induced immunity in pregnant and lactating people Obstetrics/Gynecology  
2021 Intramural CHANDRASEKAR, VAISHNAVI CDRH Effect Of Sex Differences on the Drug Absorption, Biological Responses and Adverse Events Elicited by Paclitaxel Containing Medical Devices Cardiovascular Sex differences
2021 Intramural CHANDRASEKAR, VAISHNAVI CDRH Effect Of Sex Differences on the Drug Absorption, Biological Responses and Adverse Events Elicited by Paclitaxel Containing Medical Devices Medical device  
2021 Intramural GALLAS, BRANDON CDRH Dataset to validate digital-pathology algorithms that quantify tumor-infiltrating lymphocytes in breast cancer Oncology/cancer Predominantly affects women
2021 Intramural GALLAS, BRANDON CDRH Dataset to validate digital-pathology algorithms that quantify tumor-infiltrating lymphocytes in breast cancer Diagnostics  
2021 Intramural GALLAS, BRANDON CDRH Dataset to validate digital-pathology algorithms that quantify tumor-infiltrating lymphocytes in breast cancer Artificial Intelligence  
2021 Intramural SAHINER, BERKMAN CDRH Prediction of response to therapy for advanced/metastatic breast cancer: Joint analysis of radiologic and genomic data using machine learning Oncology/cancer  
2021 Intramural SAHINER, BERKMAN CDRH Prediction of response to therapy for advanced/metastatic breast cancer: Joint analysis of radiologic and genomic data using machine learning
Artificial Intelligence
 
2021 Extramural VASHISHT, ROHIT UCSF-Stanford Learning Real-World Sex-Specific Clinical Factors Influencing the Susceptibility to Infection, Immune Response, Treatment Utilization and Outcomes Among Individuals Infected with SARS-CoV-2 Infection Infectious diseases Sex differences
2021 Intramural SHIN, HAINSWORTH CDRH Identifying the cellular impact of surface textures in relation to breast implant associated anaplastic large-cell lymphoma Oncology/cancer Predominantly affects women
2021 Intramural SHIN, HAINSWORTH CDRH Identifying the cellular impact of surface textures in relation to breast implant associated anaplastic large-cell lymphoma Medical device  
2021 Intramural YU, LI-RONG NCTR Verification of novel predictive biomarkers of doxorubicin-induced cardiotoxcity in breast cancer patients Oncology/cancer Predominantly affects women
2021 Intramural YU, LI-RONG NCTR Verification of novel predictive biomarkers of doxorubicin-induced cardiotoxcity in breast cancer patients Toxicology  
2020 Intramural DEVADAS, KRISHNAKUMAR CBER Impact of sex-based differences in the expression of host non-coding RNA biomarkers that can diagnose early HIV-1 infection Infectious diseases
 
Sex differences
2020 Intramural XIE, HANG CBER Identify unique antibody characteristics for prediction of effective influenza vaccination in pregnant and lactating women Infectious diseases
 
Only women
2020 Intramural XIE, HANG CBER Identify unique antibody characteristics for prediction of effective influenza vaccination in pregnant and lactating women Immunology  
2020 Intramural XIE, HANG CBER Identify unique antibody characteristics for prediction of effective influenza vaccination in pregnant and lactating women Obstetrics/Gynecology  
2020 Intramural BENT, ROBYN CDER Qualitative Development of Patient Preference Survey Tool for Contraception Products (Special Funding) Obstetrics/Gynecology Only women
2020 Intramural DINATALE, MIRIAM CDER Pregnancy and Lactation Labeling Rule (PLLR): Health Care Provider Testing to Improve Health Communications Related to Lactation Obstetrics/Gynecology Only women
2020 Intramural DINATALE, MIRIAM CDER Pregnancy and Lactation Labeling Rule (PLLR): Health Care Provider Testing to Improve Health Communications Related to Lactation Public Health  
2020 Intramural STONE, HEATHER CDER CURE Pregnancy Treatment Repository  Obstetrics/Gynecology Only women
2020 Intramural STONE, HEATHER CDER CURE Pregnancy Treatment Repository  Pharmaceuticals  
2020 Intramural XU, XIAOMING CDER An innovative alternative approach for assessing drug release from levonorgestrel intrauterine systems (IUSs) for supporting bioequivalence: in vitro drug release model in combination with advanced morphological characterization with micro-imaging (Special Funding) Obstetrics/Gynecology Only women
2020 Intramural XU, XIAOMING CDER An innovative alternative approach for assessing drug release from levonorgestrel intrauterine systems (IUSs) for supporting bioequivalence: in vitro drug release model in combination with advanced morphological characterization with micro-imaging (Special Funding) Medical device  
2020 Extramural LADD-ACOSTA, CHRISTINE Johns Hopkins Assessing real-world use of pharmaceuticals among pregnant women Obstetrics/Gynecology Only women
2020 Extramural LADD-ACOSTA, CHRISTINE Johns Hopkins Assessing real-world use of pharmaceuticals among pregnant women Pharmaceuticals  
2020 Intramural ELESPURU, ROSALIE CDRH Development of an integrated database for gender-based toxicological assessments (Special Funding) Toxicology Sex differences
2020 Intramural ELESPURU, ROSALIE CDRH Development of an integrated database for gender-based toxicological assessments (Special Funding) Medical device  
2020 Intramural WEIJIE, CHEN CDRH Predicting the response to hormonal treatment of women with atypical endometrial hyperplasia using artificial intelligence/machine learning (AI/ML) algorithms Oncology/cancer Only women
2020 Intramural WEIJIE, CHEN CDRH Predicting the response to hormonal treatment of women with atypical endometrial hyperplasia using artificial intelligence/machine learning (AI/ML) algorithms Biomarkers  
2020 Intramural WEIJIE, CHEN CDRH Predicting the response to hormonal treatment of women with atypical endometrial hyperplasia using artificial intelligence/machine learning (AI/ML) algorithms Artificial Intelligence  
2020 Extramural TAO, ZHANG Husson University Predicting the transfer of breast cancer resistant milk using IN VITRO to IN VIVO Extrapolation (IVIVE) Oncology/cancer Only women
2020 Extramural TAO, ZHANG Husson University Predicting the transfer of breast cancer resistant milk using IN VITRO to IN VIVO Extrapolation (IVIVE) Pharmaceuticals  
2020 Intramural CUEVAS-MARTINEZ, ELVIS-YANE NCTR Sex differences in Alzheimer’s disease associated with blood-brain barrier and immunological responses: Basis for emerging technologies for discovery of potential biomarkers and new therapies in women Neurology Sex differences
2020 Intramural CUEVAS-MARTINEZ, ELVIS-YANE NCTR Sex differences in Alzheimer’s disease associated with blood-brain barrier and immunological responses: Basis for emerging technologies for discovery of potential biomarkers and new therapies in women Biomarkers  
2020 Intramural FAHMI, TARIQ NCTR Determination of Sex Differences in Immune Responses to Nanoparticles Immunology Sex differences
2020 Intramural FAHMI, TARIQ NCTR Determination of Sex Differences in Immune Responses to Nanoparticles Toxicology  
2020 Intramural MEI, NAN NCTR Mechanistic evaluation of genotoxic potential of black cohosh, a dietary supplement widely marketed for relief of gynecologic disorders and menopausal symptoms Obstetrics/Gynecology Only women
2020 Intramural MEI, NAN NCTR Mechanistic evaluation of genotoxic potential of black cohosh, a dietary supplement widely marketed for relief of gynecologic disorders and menopausal symptoms Toxicology  
2020 Intramural MEI, NAN NCTR Mechanistic evaluation of genotoxic potential of black cohosh, a dietary supplement widely marketed for relief of gynecologic disorders and menopausal symptoms Dietary supplements  
2019 Intramural CRAVEN, BRENT CDRH Evaluating inferior vena cava filter performance in women using patient-specific computational modeling Cardiovascular Sex differences
2019 Intramural CRAVEN, BRENT CDRH Evaluating inferior vena cava filter performance in women using patient-specific computational modeling Medical device  
2019 Intramural GARCIA, MONICA CDRH Computational models to evaluate the safety and effectiveness of vaginal heating devices Obstetrics/Gynecology Only women
2019 Intramural GARCIA, MONICA CDRH Computational models to evaluate the safety and effectiveness of vaginal heating devices Medical device  
2019 Intramural DU, DONGYI (TONY) CDRH Evaluating the clinical comparibility of US vs. non-US clinical trial data for FDA-regulated medical devices for obesity treatment (co-funding with OMH) Endocrine/Metabolic  
2019 Intramural DU, DONGYI (TONY) CDRH Evaluating the clinical comparibility of US vs. non-US clinical trial data for FDA-regulated medical devices for obesity treatment (co-funding with OMH) Medical device  
2019 Intramural FAIRMAN, KIARA NCTR Development of an artificially intelligent virtual pregnant woman modeling suite to support regulatory decisions Obstetrics/Gynecology Only women
2019 Intramural FAIRMAN, KIARA NCTR Development of an artificially intelligent virtual pregnant woman modeling suite to support regulatory decisions Pharmacology  
2019 Intramural FAIRMAN, KIARA NCTR Development of an artificially intelligent virtual pregnant woman modeling suite to support regulatory decisions Artificial Intelligence  
2019 Extramural FLYNN, EMILY UCSF-Stanford Comprehensive Assessment of Sex-Differential Smoking-related Effects in Publicly Available Gene Expression Data Pulmonary Sex differences
2019 Extramural FLYNN, EMILY UCSF-Stanford Comprehensive Assessment of Sex-Differential Smoking-related Effects in Publicly Available Gene Expression Data Gene expression  
2019 Extramural

HARGRAVES, IAN

Yale-Mayo

Methods to capture post-market patient preference information Medical device Only women
2019 Intramural LYN-COOK, BEVERLY NCTR Validation of Nuclear, Cytoplasmic and Cell Surface Receptors Expression in Triple Negative Breast Cancer Subtypes Treated with Vorinostat (Special Funding) Oncology/cancer Predominantly affects women
2019 Intramural LYN-COOK, BEVERLY NCTR Validation of Nuclear, Cytoplasmic and Cell Surface Receptors Expression in Triple Negative Breast Cancer Subtypes Treated with Vorinostat (Special Funding) Biomarkers  
2019 Extramural MULLINS, DANIELS University of Maryland Health Communications Public Health Only women
2019 Extramural MULLINS, DANIELS University of Maryland Health Communications Pharmaceuticals  
2019 Extramural MULLINS, DANIELS University of Maryland Health Communications Biologics  
2019 Intramural PETRICK, NICHOLAS  CDRH Digital and 3D printed methods for quantitative CT-based bone texture and microarchitecture analysis for fracture risk (Special Funding) Musculoskeletal Sex differences
2019 Intramural TARTERA, CARMEN CFSAN Evaluation of women's targeted dietary supplements for labeling complicance and potential contamination, containing live microbes in the US market with special emphasis on pregnant and lactating women, and infants Dietary supplements Only women
2019 Intramural TARTERA, CARMEN CFSAN Evaluation of women's targeted dietary supplements for labeling complicance and potential contamination, containing live microbes in the US market with special emphasis on pregnant and lactating women, and infants Obstetrics/Gynecology  
2019 Intramural TARTERA, CARMEN CFSAN Evaluation of women's targeted dietary supplements for labeling complicance and potential contamination, containing live microbes in the US market with special emphasis on pregnant and lactating women, and infants Metagenomics  
2019 Intramural TONG, WEIDA NCTR Develop a Database of Herbal/ Dietary Supplements (HDS) Hepatotoxicity to Support the Agency’s New Efforts to Strengthen Regulation of HDS Products (extension of FY16 project) (Special Funding) Hepatic  
2019 Intramural TONG, WEIDA NCTR Develop a Database of Herbal/ Dietary Supplements (HDS) Hepatotoxicity to Support the Agency’s New Efforts to Strengthen Regulation of HDS Products (extension of FY16 project) (Special Funding)
 
Dietary supplements  
2019 Extramural WebMD WebMD Survey- Lupus Patient Perspective on Clinical Trials Autoimmune  
2019 Extramural WebMD WebMD Survey- Lupus Patient Perspective on Clinical Trials Clinical Trials  
2019 Extramural WebMD WebMD Survey- Lupus Prescriber Referral Bias Autoimmune  
2019 Extramural WebMD WebMD Survey- Lupus Prescriber Referral Bias Clinical Trials  
2019 Extramural WebMD WebMD Survey-Women's Health Special Populations Obstetrics/Gynecology Only women
2019 Extramural WebMD WebMD Survey-Women's Health Special Populations Pharmaceuticals  
2019 Extramural WU, JOSEPH UCSF-Stanford Identifying genetic mechanisms of doxorubicin-induced cardiotoxcity Oncology/cancer sex differences
2019 Extramural WU, JOSEPH UCSF-Stanford Identifying genetic mechanisms of doxorubicin-induced cardiotoxcity Toxicology  
2019 Intramural WU, WEN JIN CDER Develop novel bispecific antibodies to improve the safety and efficacy of FDA-regulated products for the treatment of triple negative breast cancers (Special Funding) Oncology/cancer Predominantly affects women
2019 Intramural WU, WEN JIN CDER Develop novel bispecific antibodies to improve the safety and efficacy of FDA-regulated products for the treatment of triple negative breast cancers (Special Funding) Biologics  
2019 Intramural YU, LI-RONG  NCTR Verification of Novel Predictive Biomarkers of Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients Oncology/cancer Predominantly affects women
2019 Intramural YU, LI-RONG  NCTR Verification of Novel Predictive Biomarkers of Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients Toxicology  
2019 Intramural ZHUANG, LUNING CDER Application of model-informed approaches to facilicate dose selection for antimalarial drugs in pregnant women to support efficient drug development Infectious disease  
2019 Intramural ZIRKELBACH, JEANNE FOURIE CDER Patient reported outcomes (PRO) symptom data to complement traditional exposure-response (ER) analysis to optimize dose selection and dose reduction strategies during adjuvant breast cancer treatment drug development Oncology/cancer Predominantly affects women
2019 Intramural ZIRKELBACH, JEANNE FOURIE CDER Patient reported outcomes (PRO) symptom data to complement traditional exposure-response (ER) analysis to optimize dose selection and dose reduction strategies during adjuvant breast cancer treatment drug development Patient-reported outcomes  
2018 Intramural GUERRIERI, GIOIA CDER Plasma biomarkers in perimenopause-onset depression Psychiatry Only women
2018 Intramural GUERRIERI, GIOIA CDER Plasma biomarkers in perimenopause-onset depression Biomarkers  
2018 Intramural GUERRIERI, GIOIA CDER Plasma biomarkers in perimenopause-onset depression Obstetrics/Gynecology  
2018 Intramural JU, JING CDER Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products Public Health Only women
2018 Intramural PANG, LI NCTR Sex differences in drug-induced QT prolongation and Torsades de pointes establishing an in vitro model for high-throughput screening and risk assessment of torsadogenic drugs (special funding) Cardiovascular Sex differences
2018 Intramural PANG, LI NCTR Sex differences in drug-induced QT prolongation and Torsades de pointes establishing an in vitro model for high-throughput screening and risk assessment of torsadogenic drugs (special funding) Gene expression  
2018 Intramural RAJAN, SUNDER CDRH Development of a Standardized Protocol for Screening and Detection of ALCL and implant rupture through High Resolution 3D MRI imaging of silicone breast implants QC title - Standardizing the protocol for High-resolution 3D MRI for imaging silicone breast implants for screening and detection of ALCL Oncology/cancer Predominantly affects women
2018 Intramural RAJAN, SUNDER CDRH Development of a Standardized Protocol for Screening and Detection of ALCL and implant rupture through High Resolution 3D MRI imaging of silicone breast implants QC title - Standardizing the protocol for High-resolution 3D MRI for imaging silicone breast implants for screening and detection of ALCL Medical device  
2018 Intramural SAHA, ANINDITA  CDRH Analysis of Sex Specific Differences in Quality of Life Measures for Heart Failure Cardiovascular Sex differences
2018 Intramural SAHA, ANINDITA  CDRH Analysis of Sex Specific Differences in Quality of Life Measures for Heart Failure Patient-reported outcomes  
2018 Intramural SHIN, HAINSWORTH CDRH Identifying the impact of surface-texturing on the differential pathogenesis of Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL) Oncology/cancer Predominantly affects women
2018 Intramural SHIN, HAINSWORTH CDRH Identifying the impact of surface-texturing on the differential pathogenesis of Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL) Medical device  
2018 Intramural ZUSTERZEEL, ROBBERT CDER Evaluation of the Safety and Effectiveness of Non-Vitamin K Antagonist Oral Anticoagulants (NOACs) for Atrial Fibrillation in Underrepresented Subgroups in Premarket Clinical Trials Using Combined Clinical and Statistical Modeling Approaches. (special funding) Cardiovascular Sex differences
2018 Intramural ZUSTERZEEL, ROBBERT CDER Evaluation of the Safety and Effectiveness of Non-Vitamin K Antagonist Oral Anticoagulants (NOACs) for Atrial Fibrillation in Underrepresented Subgroups in Premarket Clinical Trials Using Combined Clinical and Statistical Modeling Approaches. (special funding) Medical device  
2017 Intramural ZUSTERZEEL, ROBBERT CDER Evaluation of the Safety and Effectiveness of Non-Vitamin K Antagonist Oral Anticoagulants (NOACs) for Atrial Fibrillation in Underrepresented Subgroups in Premarket Clinical Trials Using Combined Clinical and Statistical Modeling Approaches. (special funding) Pharmaceuticals  
2017 Intramural ELEKAWACHI, OLUCHI CBER Evaluation of the extent and impact of gender sensitive advertising and promotional labeling of Health Products (Special Funding) Public Health Gender differences
2017 Intramural ELEKAWACHI, OLUCHI CBER Evaluation of the extent and impact of gender sensitive advertising and promotional labeling of Health Products (Special Funding) Public Health  
2017 Intramural FERGUSON, SHERRY NCTR Gender differences related to Alzheimer's disease as revealed by Exome sequencing and RNA Seq (Special Funding) Neurology Sex differences
2017 Intramural FERGUSON, SHERRY NCTR Gender differences related to Alzheimer's disease as revealed by Exome sequencing and RNA Seq (Special Funding) Biomarkers  
2017 Intramural FERGUSON, SHERRY NCTR Gender differences related to Alzheimer's disease as revealed by Exome sequencing and RNA Seq (Special Funding) Gene expression  
2017 Intramural FUSCOE, JAMES NCTR Evaluation of transcriptomics-based predictions of sex- and age-related susceptibilities to treatment-induced adverse effects in F344 rats (Special Funding) Endocrine/Metabolic Sex differences
2017 Intramural FUSCOE, JAMES NCTR Evaluation of transcriptomics-based predictions of sex- and age-related susceptibilities to treatment-induced adverse effects in F344 rats (Special Funding) Gene expression  
2017 Intramural FUSCOE, JAMES NCTR Evaluation of transcriptomics-based predictions of sex- and age-related susceptibilities to treatment-induced adverse effects in F344 rats (Special Funding) Pharmaceuticals  
2017 Intramural JIANG, HELEN CDRH Sex-specific analysis of percutaneous left atrial appendage (LAA) closure device for stroke prevention in patients with atrial fibrillation Cardiovascular Sex differences
2017 Intramural LUMEN, ANNIE NCTR Population-Based computational framework for assessing xenobiotic disposition and interaction effects in pregnant women Obstetrics/Gynecology Only women
2017 Intramural LUMEN, ANNIE NCTR Population-Based computational framework for assessing xenobiotic disposition and interaction effects in pregnant women Pharmacology  
2017 Intramural LUMEN, ANNIE NCTR Population-Based computational framework for assessing xenobiotic disposition and interaction effects in pregnant women
 
Endocrine/Metabolic  
2017 Intramural LYN-COOK, BEVERLY NCTR Stimulate innovation in clinical evaluations and personalized medicine to improve patient outcomes with triple negative breast cancer Oncology/cancer Predominantly affects women
2017 Intramural RAJAN, SUNDER; ANGELONE, LEONARDO CDRH Virtual model of a female human subject with large body habitus for use in MR Radio frequency safety assessments Medical device  
2017 Intramural STRAUSS, DAVID CDER Translational regulatory science to advance drug safety in women combining in silico modeling and clinical approaches Cardiovascular Sex differences
2017 Intramural TOROSYAN, YELIZAVETA CDRH In silico research on sex differences in the biological responses and adverse events elicited by implantable devices/ biomaterials (Special funding) Medical device Sex differences
2017 Intramural TOROSYAN, YELIZAVETA CDRH In silico research on sex differences in the biological responses and adverse events elicited by implantable devices/ biomaterials (Special funding) Biomarkers  
2017 Intramural YU, LI-RONG NCTR Predictive clinical biomarkers for chemotherapy induced cardiotoxicity (Special Funding) Oncology/cancer Predominantly affects women
2017 Intramural YU, LI-RONG NCTR Predictive clinical biomarkers for chemotherapy induced cardiotoxicity (Special Funding) Toxicology  
2017 Intramural YU, LI-RONG NCTR Predictive clinical biomarkers for chemotherapy induced cardiotoxicity (Special Funding) Biomarkers  
2016 Intramural BUEHLER, PAUL CBER Evaluation of thromboembolic events following C1-inhibitor therapy Rare Diseases Predominantly affects women
2016 Intramural BUEHLER, PAUL CBER Evaluation of thromboembolic events following C1-inhibitor therapy Pharmaceuticals  
2016 Intramural DAS, SRILEKHA CDRH Bacteria and virus migration through latex condoms in the presence of personal lubricants Obstetrics/Gynecology  
2016 Intramural DAS, SRILEKHA CDRH Bacteria and virus migration through latex condoms in the presence of personal lubricants Infectious disease  
2016 Intramural DAS, SRILEKHA CDRH Bacteria and virus migration through latex condoms in the presence of personal lubricants Medical device  
2016 Intramural DU, DONGYI CDRH Sex and racial difference in prosthetic aortic valve selection and risk factors for patient outcome—an observational study of Medicare beneficiaries Cardiovascular Sex differences
2016 Intramural DU, DONGYI CDRH Sex and racial difference in prosthetic aortic valve selection and risk factors for patient outcome—an observational study of Medicare beneficiaries Medical device  
2016 Intramural GARRA, BRIAN CDRH Spectral Photoacoustic Tomography (PAT) for Breast Tumor Oximetry: Test Method Development, In Vivo Validation, and Computational Modeling Oncology/cancer Predominantly affects women
2016 Intramural GARRA, BRIAN CDRH Spectral Photoacoustic Tomography (PAT) for Breast Tumor Oximetry: Test Method Development, In Vivo Validation, and Computational Modeling Medical device  
2016 Intramural LEE, LAI MING CDER Cardiovascular Risk of Testosterone Treatment in Women Cardiovascular Only women
2016 Intramural LEE, LAI MING CDER Cardiovascular Risk of Testosterone Treatment in Women Obstetrics/Gynecology  
2016 Intramural LYN-COOK, BEVERLY NCTR The role of epigenetic mechanisms in re-expression of ER, PR, and HER receptors in triple negative breast cancer: effects of FDA approved epigenetic drugs and dietary agents  Oncology/cancer Predominantly affects women
2016 Intramural LYN-COOK, BEVERLY NCTR The role of epigenetic mechanisms in re-expression of ER, PR, and HER receptors in triple negative breast cancer: effects of FDA approved epigenetic drugs and dietary agents  Pharmaceuticals  
2016 Intramural MYERS, MATTHEW CDRH Development of test methods to evaluate the risk of cancer-cell permeation through tissue containment bags during laparoscopic power morcellation of uterine fibroids Oncology/cancer  
2016 Intramural MYERS, MATTHEW CDRH Development of test methods to evaluate the risk of cancer-cell permeation through tissue containment bags during laparoscopic power morcellation of uterine fibroids Medical device  
2016 Intramural NAGARAJA, SRINIDHI BAUMANN, ANDREW CDRH Improving assessment of spinal device subsidence by incorporating female anatomy and density Musculoskeletal Sex differences
2016 Intramural NAGARAJA, SRINIDHI BAUMANN, ANDREW CDRH Improving assessment of spinal device subsidence by incorporating female anatomy and density Medical device  
2016 Intramural PATRI, ANIL NCTR Evaluating the migration and toxic potential of silver nanoparticles in feminine hygiene products into vaginal tissue: In vivo rodent and human in vitro 3D mucosal models Obstetrics/Gynecology Only women
2016 Intramural PATRI, ANIL NCTR Evaluating the migration and toxic potential of silver nanoparticles in feminine hygiene products into vaginal tissue: In vivo rodent and human in vitro 3D mucosal models Toxicology  
2016 Intramural PETRICK, NICHOLAS CDRH Calcium and material characterization in women using dual-energy CT: Phase II Cardiovascular Sex differences
2016 Intramural PETRICK, NICHOLAS CDRH Calcium and material characterization in women using dual-energy CT: Phase II Medical device  
2016 Intramural PEZESHK, ARIA CDRH Preservation of relevant clinical information in lossy compressed digital mammograms using objective image quality metrics Oncology/cancer Predominantly affects women
2016 Intramural PEZESHK, ARIA CDRH Preservation of relevant clinical information in lossy compressed digital mammograms using objective image quality metrics Medical device  
2016 Intramural SADRIEH, NAKISSA CFSAN Non-clinical mechanistic studies in addressing ovarian cancer risk from talc use in cosmetics (Special funding) Oncology/cancer Only women
2016 Intramural SADRIEH, NAKISSA CFSAN Non-clinical mechanistic studies in addressing ovarian cancer risk from talc use in cosmetics (Special funding) Cosmetics  
2016 Intramural SAHINER, BERKMAN CDRH Mammographic CAD device testing using computationally inserted microcalcification clusters and masses Oncology/cancer Predominantly affects women
2016 Intramural SAHINER, BERKMAN CDRH Mammographic CAD device testing using computationally inserted microcalcification clusters and masses Medical device  
2016 Intramural SAHINER, BERKMAN CDRH Mammographic CAD device testing using computationally inserted microcalcification clusters and masses Method development & validation  
2016 Intramural STRUBLE, EVI CBER Assessment of Placental Transmission of Zika Virus Glycoprotein E Immunogen Obstetrics/Gynecology Only women
2016 Intramural STRUBLE, EVI CBER Assessment of Placental Transmission of Zika Virus Glycoprotein E Immunogen Infectious diseases  
2016 Intramural TONG, WEIDA NCTR Hepatotoxicity database for herbal/dietary supplements Hepatic  
2016 Intramural TONG, WEIDA NCTR Hepatotoxicity database for herbal/dietary supplements Toxicology  
2016 Intramural TONG, WEIDA NCTR Hepatotoxicity database for herbal/dietary supplements Dietary Supplements  
2016 Intramural WAGNER, DOUG NCTR Drug-delivery nanoparticle immunological effects on induction of pro-inflammatory responses to Candida albicans in mice Immunology Only women
2016 Intramural WAGNER, DOUG NCTR Drug-delivery nanoparticle immunological effects on induction of pro-inflammatory responses to Candida albicans in mice Obstetrics/Gynecology  
2016 Intramural WEAR, KEITH CDRH Advancing Methods for Assessment and Prediction of Clinical Performance of High Intensity Therapeutic Ultrasound Systems (special funding) Medical device  
2016 Intramural WEAR, KEITH CDRH Advancing Methods for Assessment and Prediction of Clinical Performance of High Intensity Therapeutic Ultrasound Systems (special funding) Method development & validation  
2016 Intramural WU, WEN JIN CDER Development of biomarkers for trastuzumab-induced toxicity Oncology/cancer Predominantly affects women
2016 Intramural WU, WEN JIN CDER Development of biomarkers for trastuzumab-induced toxicity Toxicology  
2016 Intramural WU, WEN JIN CDER Development of biomarkers for trastuzumab-induced toxicity Biomarkers  
2016 Intramural WU, WENDY CDER Optimization of an in silico cardiac cell model for predicting sex differences in drug-induced proarrhythmia risk Cardiovascular sex differences
2016 Intramural YU, JINGYU CDER Tool development of modeling and simulations for metastatic breast cancer Oncology/cancer Predominantly affects women
2015 Intramural CANOS, DANIEL CDRH Sex-specific outcomes with cardiac resynchronization therapy  Cardiovascular Sex differences
2015 Intramural CANOS, DANIEL CDRH Sex-specific outcomes with cardiac resynchronization therapy  Medical device  
2015 Intramural CANOS, DANIEL CDRH Individual patient-data meta-analysis and post-market analysis as a method for improving data quality in demographic subgroups Cardiovascular Sex differences
2015 Intramural CANOS, DANIEL CDRH Individual patient-data meta-analysis and post-market analysis as a method for improving data quality in demographic subgroups Medical device  
2015 Intramural CANOS, DANIEL CDRH Individual patient-data meta-analysis and post-market analysis as a method for improving data quality in demographic subgroups Clinical Trials  
2015 Intramural COBURN, JAMES CDRH Sex-specific modeling and analysis of ACL injury susceptibility Musculoskeletal Sex differences
2015 Intramural COBURN, JAMES CDRH Sex-specific modeling and analysis of ACL injury susceptibility Medical device  
2015 Intramural LI, XIANG  CBER Bayesian demographic subgroup analyses for pregnant women Obstetrics/Gynecology Only women
2015 Intramural LI, XIANG  CBER Bayesian demographic subgroup analyses for pregnant women Clinical trials  
2015 Intramural LIACHENKO, SERGUEI NCTR Gender differences in neuronal reward circuit activation by nicotine and tobacco smoke using magnetic resonance spectroscopy Neurology  
2015 Intramural LUMEN, ANNIE NCTR Population-based computational framework for assessing xenobiotic disposition and interaction effects in pregnant women (Supplementary funds) Obstetrics/Gynecology Only women
2015 Intramural LUMEN, ANNIE NCTR Population-based computational framework for assessing xenobiotic disposition and interaction effects in pregnant women (Supplementary funds) Endocrine/Metabolic  
2015 Intramural MARINAC, DANICA CDRH Capturing Sex-Specific Data in  Regulatory Submissions and National Vascular Quality Initiative Registry  Cardiovascular Sex differences
2015 Intramural MARINAC, DANICA CDRH Capturing Sex-Specific Data in  Regulatory Submissions and National Vascular Quality Initiative Registry  Medical device  
2015 Intramural MYERS, MEAGAN NCTR Oncomutation profile of triple negative breast cancer: Additional studies in African American women Oncology/cancer Predominantly affects women
2015 Intramural MYERS, MEAGAN NCTR Oncomutation profile of triple negative breast cancer: Additional studies in African American women Biomarkers  
2015 Intramural NAGARAJA, SRINIDHI CDRH The effects of gender differences in adverse events for integrated fixation spinal implants Muscoloskeletal Sex differences
2015 Intramural NAGARAJA, SRINIDHI CDRH The effects of gender differences in adverse events for integrated fixation spinal implants Medical device  
2015 Intramural OVANESOV, MIKHAIL CBER Effect of procoagulant impurity on coagulation in plasma from pregnant women  Hematologic Only women
2015 Intramural OVANESOV, MIKHAIL CBER Effect of procoagulant impurity on coagulation in plasma from pregnant women  Obstetrics/Gynecology  
2015 Intramural PANG, LI NCTR A pilot study for evaluating genetic influences on sex differences of drug-induced proarrhythmia Cardiovascular Sex differences
2015 Intramural PANG, LI NCTR A pilot study for evaluating genetic influences on sex differences of drug-induced proarrhythmia Pharmaceuticals  
2015 Intramural PHILLIPS, KENNETH CDRH Bacterial colonization and biofilm formation in dermal fillers implants: An in vivo model to confirm in vitro findings and pathogenesis leading to adverse events Dermatology Predominantly affects women
2015 Intramural PHILLIPS, KENNETH CDRH Bacterial colonization and biofilm formation in dermal fillers implants: An in vivo model to confirm in vitro findings and pathogenesis leading to adverse events Medical device  
2015 Intramural RAO, V ASHUTOSH CDER Addressing the unmet medical needs for cardioprotection in women receiving chemotherapy Oncology/cancer Sex differences
2015 Intramural RAO, V ASHUTOSH CDER Addressing the unmet medical needs for cardioprotection in women receiving chemotherapy Toxicology  
2015 Intramural RONK, CHRISTOPHER CDRH Inclusion of Minority Racial/Ethnic Subjects in OB-GYN Device Applications and Device Labeling, 2005-2015 (Special Funding) Obstetrics/Gynecology Sex differences
2015 Intramural RONK, CHRISTOPHER CDRH Inclusion of Minority Racial/Ethnic Subjects in OB-GYN Device Applications and Device Labeling, 2005-2015 (Special Funding) Medical device  
2015 Intramural STRAUSS, DAVID CDER Ensuring Accessible Supply of Safe and Effective Drugs: Quantifying Women-Specific Pro-Arrhythmia Risk of Drug Therapies (Special Funding) Cardiovascular Sex differences
2015 Intramural STRAUSS, DAVID CDER Ensuring Accessible Supply of Safe and Effective Drugs: Quantifying Women-Specific Pro-Arrhythmia Risk of Drug Therapies (Special Funding) Pharmaceuticals  
2015 Intramural STRUBLE, EVI CBER Treating the pregnant patient: pharmacokinetic and mechanistic studies of antiviral IGIV preparations at different stages of gestation in an animal model of pregnancy Obstetrics/Gynecology Only women
2015 Intramural STRUBLE, EVI CBER Treating the pregnant patient: pharmacokinetic and mechanistic studies of antiviral IGIV preparations at different stages of gestation in an animal model of pregnancy Pharmacology  
2015 Intramural STRUBLE, EVI CBER Treating the pregnant patient: pharmacokinetic and mechanistic studies of antiviral IGIV preparations at different stages of gestation in an animal model of pregnancy Infectious diseases  
2015 Intramural WOODS, TERRY CDRH Identifying and characterizing key mechanical characteristics of surgical meshes used for pelvic organ prolapse repair and treatment of stress Obstetrics/Gynecology Only women
2015 Intramural WOODS, TERRY CDRH Identifying and characterizing key mechanical characteristics of surgical meshes used for pelvic organ prolapse repair and treatment of stress Medical device  
2015 Intramural WOODS, TERRY CDRH Preclinical test methods for percutaneously implanted heart valves - Effect of non-circular valve configuration after implantation on valve leaflet dynamics Cardiovascular Predominantly affects women
2015 Intramural WOODS, TERRY CDRH Preclinical test methods for percutaneously implanted heart valves - Effect of non-circular valve configuration after implantation on valve leaflet dynamics Medical device  
2015 Intramural XIE, HANG CBER Modulatory effects of progesterone on maternal immunity and their implications in pregnancy-associated susceptibility to avian influenza infections Infectious diseases Only women
2015 Intramural XIE, HANG CBER Modulatory effects of progesterone on maternal immunity and their implications in pregnancy-associated susceptibility to avian influenza infections Obstetrics/Gynecology  
2015 Intramural XIE, HANG CBER Modulatory effects of progesterone on maternal immunity and their implications in pregnancy-associated susceptibility to avian influenza infections Immunology  
2014 Intramural CHANG, CHING-WEI NCTR Blood pressure threshold for cardiovascular disease risk: an assessment of sex-based criterion Cardiovascular Sex differences
2014 Intramural CHANG, CHING-WEI NCTR Blood pressure threshold for cardiovascular disease risk: an assessment of sex-based criterion Diagnostics  
2014 Intramural GARRA, BRIAN CDRH Phantom-based evaluation of photoacoustic imaging systems for breast tumor vasculature quantification Oncology/cancer Predominantly affects women
2014 Intramural GARRA, BRIAN CDRH Phantom-based evaluation of photoacoustic imaging systems for breast tumor vasculature quantification Medical device  
2014 Intramural GARRA, BRIAN CDRH Phantom-based evaluation of photoacoustic imaging systems for breast tumor vasculature quantification Method development & validation  
2014 Intramural GELPERIN, KATE CDER Evaluation and Improvement of Post-Market Pregnancy Registries Obstetrics/Gynecology Only women
2014 Intramural HART, MARK NCTR Evaluation of methods used to measure growth of staphylococcus aureus and the production of toxic shock syndrome toxin-1 as influenced by menstrual tampons Infectious diseases Only women
2014 Intramural HART, MARK NCTR Evaluation of methods used to measure growth of staphylococcus aureus and the production of toxic shock syndrome toxin-1 as influenced by menstrual tampons Medical device  
2014 Intramural HART, MARK NCTR Evaluation of methods used to measure growth of staphylococcus aureus and the production of toxic shock syndrome toxin-1 as influenced by menstrual tampons Obstetrics/Gynecology  
2014 Intramural LI, LI CDER Disease systems analysis: towards a generic framework for characterizing disease progression and treatment effects in osteoporosis Musculoskeletal Predominantly affects women
2014 Intramural LI, LI CDER Disease systems analysis: towards a generic framework for characterizing disease progression and treatment effects in osteoporosis Pharmaceuticals  
2014 Intramural LI, XIANG (JUDY) CBER Bayesian assessment of safety profiles for pregnant women-From animal study to human clinical trial Obstetrics/Gynecology Only women
2014 Intramural OVANESOV, MIKHAIL CBER Evaluation of pharmacokinetics of thrombogenic impurity following different routes of immune globulin administration during pregnancy Obstetrics/Gynecology Only women
2014 Intramural OVANESOV, MIKHAIL CBER Evaluation of pharmacokinetics of thrombogenic impurity following different routes of immune globulin administration during pregnancy Immunology  
2014 Intramural PANG, LI NCTR Sex differences in drug-induced QT prolongation and torsade de pointes: establishing an in vitro model for high-throughput screening and risk assessment of torsadogenic drugs Cardiovascular Sex differences
2014 Intramural PANG, LI NCTR Sex differences in drug-induced QT prolongation and torsade de pointes: establishing an in vitro model for high-throughput screening and risk assessment of torsadogenic drugs Gene expression  
2014 Intramural PARISER, ANNE CDER Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products (Special Funding) Pharmaceuticals Sex differences
2014 Intramural PARISER, ANNE CDER Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products (Special Funding) Biologics  
2014 Intramural PETRICK, NICHOLAS CDRH Calcium and material characterization in women using dual-energy computed tomography Cardiovascular Sex differences
2014 Intramural PETRICK, NICHOLAS CDRH Calcium and material characterization in women using dual-energy computed tomography Medical device  
2014 Intramural SAHINER, BERKMAN CDRH Simulation of realistic masses on mammograms and digital breast tomosynthesis images for system assessment and CAD development/testing Oncology/cancer Predominantly affects women
2014 Intramural SAHINER, BERKMAN CDRH Simulation of realistic masses on mammograms and digital breast tomosynthesis images for system assessment and CAD development/testing Medical device  
2014 Intramural STOCKBRIDGE, NORMAN CDER Novel therapeutic approaches to prevent drug-induced torsade de pointes Cardiovascular Sex differences
2014 Intramural STOCKBRIDGE, NORMAN CDER Novel therapeutic approaches to prevent drug-induced torsade de pointes Pharmacology  
2014 Intramural STOCKBRIDGE, NORMAN CDER Novel therapeutic approaches to prevent drug-induced torsade de pointes Pharmaceuticals  
2014 Intramural WILSON, PHYLLIS ORA Detection of synthetic drugs as adulterants in natural and herbal slimming products by UPLC-mass spectrometry Dietary supplements Predominantly affects women
2014 Intramural WILSON, PHYLLIS ORA Detection of synthetic drugs as adulterants in natural and herbal slimming products by UPLC-mass spectrometry Method development & validation  
2014 Intramural WOOD, STEVEN CDRH Follicle-stimulating hormone (FSH) may exacerbate local and systemic effects of wear particles released from metal-on-metal hip implants: Implications for women Obstetrics/Gynecology Predominantly affects women
2014 Intramural WOOD, STEVEN CDRH Follicle-stimulating hormone (FSH) may exacerbate local and systemic effects of wear particles released from metal-on-metal hip implants: Implications for women Medical device  
2014 Intramural WOOD, STEVEN CDRH Follicle-stimulating hormone (FSH) may exacerbate local and systemic effects of wear particles released from metal-on-metal hip implants: Implications for women Immunology  
2014 Intramural WU, WEN JIN CDER Develop animal and cellular models to investigate the mechanisms of cardiotoxicity induced by trastuzumab, trastuzumab/pertuzumab, and ado-trastuzumab emtansine to support post-marketing surveillance of these antibody-based HER2-targeted therapies, and characterize novel serum biomarker of cardiotoxicity induced by trastuzumab, trastuzumab/pertuzumab, and ado-trastuzumab emtansine Oncology/cancer Predominantly affects women
2014 Intramural WU, WEN JIN CDER Develop animal and cellular models to investigate the mechanisms of cardiotoxicity induced by trastuzumab, trastuzumab/pertuzumab, and ado-trastuzumab emtansine to support post-marketing surveillance of these antibody-based HER2-targeted therapies, and characterize novel serum biomarker of cardiotoxicity induced by trastuzumab, trastuzumab/pertuzumab, and ado-trastuzumab emtansine Toxicology  
2013 Intramural WU, WEN JIN CDER Develop animal and cellular models to investigate the mechanisms of cardiotoxicity induced by trastuzumab, trastuzumab/pertuzumab, and ado-trastuzumab emtansine to support post-marketing surveillance of these antibody-based HER2-targeted therapies, and characterize novel serum biomarker of cardiotoxicity induced by trastuzumab, trastuzumab/pertuzumab, and ado-trastuzumab emtansine Biomarkers  
2013 Intramural BROWN, RONALD CDRH Sex differences in biomarkers of kidney injury in patients with metal-on-metal hip implants Renal Sex differences
2013 Intramural BROWN, RONALD CDRH Sex differences in biomarkers of kidney injury in patients with metal-on-metal hip implants Medical device  
2013 Intramural BROWN, RONALD CDRH Sex differences in biomarkers of kidney injury in patients with metal-on-metal hip implants Biomarkers  
2013 Intramural COBURN, JAMES CDER Mechanical causes of higher hip implant failure rates in women Musculoskeletal Only women
2013 Intramural COBURN, JAMES CDER Mechanical causes of higher hip implant failure rates in women Medical device  
2013 Intramural GELPERIN, KATE CDER Evaluation and Improvement of Post-Market Pregnancy Registries  Obstetrics/Gynecology Only women
2013 Intramural GELPERIN, KATE CDER Evaluation and Improvement of Post-Market Pregnancy Registries  Pharmaceuticals  
2013 Intramural HEWLETT, INDIRA CBER Evaluation of HSV-2 co-infection and hormonal contraceptive use on HIV acquisition and pathogenesis using patient-derived clinical specimens Infectious diseases Sex differences
2013 Intramural HEWLETT, INDIRA CBER Evaluation of HSV-2 co-infection and hormonal contraceptive use on HIV acquisition and pathogenesis using patient-derived clinical specimens Obstetrics/Gynecology  
2013 Intramural HEWLETT, INDIRA CBER Evaluation of HSV-2 co-infection and hormonal contraceptive use on HIV acquisition and pathogenesis using patient-derived clinical specimens Biomarkers  
2013 Extramural INGBER, DONALD Harvard Tissue on a Chip Organ chip models Sex differences
2013 Extramural INGBER, DONALD Harvard Tissue on a Chip Oncology/cancer Predominantly affects women
2013 Extramural INGBER, DONALD Harvard Tissue on a Chip Pharmaceuticals  
2013 Intramural KIM, DO-HYUN CDRH Photo-Thermal Safety in Laser-based Devices for Detection and Treatment of Breast Cancer: Effect of Endogenous Absorbers and Gold Nano-Particles Oncology/cancer Predominantly affects women
2013 Intramural KIM, DO-HYUN CDRH Photo-Thermal Safety in Laser-based Devices for Detection and Treatment of Breast Cancer: Effect of Endogenous Absorbers and Gold Nano-Particles Medical device  
2013 Intramural LUMEN, ANNIE NCTR Population-Based Computational Framework for Assessing Xenobiotic Disposition and Interaction Effects in Pregnant Women-Pilot Study Endocrine/Metabolic Only women
2013 Intramural LUMEN, ANNIE NCTR Population-Based Computational Framework for Assessing Xenobiotic Disposition and Interaction Effects in Pregnant Women-Pilot Study Obstetrics/Gynecology  
2013 Intramural LYN-COOK, BEVERLY NCTR Clinical and Biological Significance of Three Identified Targets in Systemic Lupus Erythematosus Patient PBMCs: IL-18, TNFSF13B, and FOXP3 Autoimmune Predominantly affects women
2013 Intramural LYN-COOK, BEVERLY NCTR Clinical and Biological Significance of Three Identified Targets in Systemic Lupus Erythematosus Patient PBMCs: IL-18, TNFSF13B, and FOXP3 Biomarkers  
2013 Intramural NAGARAJA, SRINIDHI CDRH The Effects of Gender Differences in Revision Rates for Spinal Total Disc Replacement Procedures Musculoskeletal Sex differences
2013 Intramural NAGARAJA, SRINIDHI CDRH The Effects of Gender Differences in Revision Rates for Spinal Total Disc Replacement Procedures Medical device  
2013 Intramural PHILLIPS, KENNETH CDRH Effect of Injection Techniques, Materials Chemistry and Physical Properties of Dermal Fillers on Potential for Bacterial Colonization and Infection Infectious diseases Predominantly affects women
2013 Intramural PHILLIPS, KENNETH CDRH Effect of Injection Techniques, Materials Chemistry and Physical Properties of Dermal Fillers on Potential for Bacterial Colonization and Infection Medical device  
2013 Intramural PHILLIPS, KENNETH CDRH Effect of Injection Techniques, Materials Chemistry and Physical Properties of Dermal Fillers on Potential for Bacterial Colonization and Infection Cosmetics  
2013 Intramural RAJAN, SUNDER CDRH MRI Safety Testing of Breast Tissue Expanders used in Mastectomy Patients Medical device Predominantly affects women
2013 Intramural STOCKBRIDGE, NORMAN; STRAUSS, DAVID CDRH PK analysis of the samples for a study funded by CDER Critical Pathways titled, “A double-blind, randomized, placebo-controlled single-dose, five-period crossover study of the electrocardiographic effects of ranolazine, dofetilide, verapamil and quinidine in healthy subjects” Cardiovascular Sex differences
2013 Intramural STOCKBRIDGE, NORMAN; STRAUSS, DAVID CDRH PK analysis of the samples for a study funded by CDER Critical Pathways titled, “A double-blind, randomized, placebo-controlled single-dose, five-period crossover study of the electrocardiographic effects of ranolazine, dofetilide, verapamil and quinidine in healthy subjects” Pharmacology  
2013 Intramural STOCKBRIDGE, NORMAN; STRAUSS, DAVID CDRH PK analysis of the samples for a study funded by CDER Critical Pathways titled, “A double-blind, randomized, placebo-controlled single-dose, five-period crossover study of the electrocardiographic effects of ranolazine, dofetilide, verapamil and quinidine in healthy subjects” Pharmaceuticals  
2013 Intramural STRUBLE, EVI CBER Assessing Passive Prophylaxis of Infection at Different Stages during Gestation in a Pregnant Animal Model Immunology Only women
2013 Intramural STRUBLE, EVI CBER Assessing Passive Prophylaxis of Infection at Different Stages during Gestation in a Pregnant Animal Model Obstetrics/Gynecology  
2013 Intramural STRUBLE, EVI CBER Assessing Passive Prophylaxis of Infection at Different Stages during Gestation in a Pregnant Animal Model Infectious diseases  
2013 Intramural VERTHELYI, DANIELA CDER Use of innate immune response modulators in women: The perfect storm to trigger autoimmune disease? Immunology Predominantly affects women
2013 Intramural VERTHELYI, DANIELA CDER Use of innate immune response modulators in women: The perfect storm to trigger autoimmune disease? Autoimmune  
2013 Intramural WAGNER, ROBERT NCTR Nanoparticle Effects on Induction of Pro-inflammatory Responses to Candida albicans by Cultured Vaginal Epithelial Cells Obstetrics/Gynecology Only women
2013 Intramural WAGNER, ROBERT NCTR Nanoparticle Effects on Induction of Pro-inflammatory Responses to Candida albicans by Cultured Vaginal Epithelial Cells Pharmaceuticals  
2013 Intramural ZHANG, ZHIWEI CDRH Incremental Values of Sequential Procedures for Diagnosing Breast Cancer Oncology/cancer Predominantly affects women
2013 Intramural ZHANG, ZHIWEI CDRH Incremental Values of Sequential Procedures for Diagnosing Breast Cancer Medical device  
2012 Intramural ZHANG, ZHIWEI CDRH Incremental Values of Sequential Procedures for Diagnosing Breast Cancer Method development & validation  
2012 Intramural ANDERSON-SMITS, COLIN CDRH A Comparative Analysis of Adverse Events Between Conventional Tubal Ligation and Transcervical Occlusive Devices of the Fallopian Tube for Female Sterilization: A Cohort Study Obstetrics/Gynecology Only women
2012 Intramural ANDERSON-SMITS, COLIN CDRH A Comparative Analysis of Adverse Events Between Conventional Tubal Ligation and Transcervical Occlusive Devices of the Fallopian Tube for Female Sterilization: A Cohort Study Medical device  
2012 Intramural ANGELONE, LEONARDO CDRH MRI in pregnant patients: A systematic analysis of Radio-frequency heating with multi-transmit technology Obstetrics/Gynecology Only women
2012 Intramural ANGELONE, LEONARDO CDRH MRI in pregnant patients: A systematic analysis of Radio-frequency heating with multi-transmit technology Medical device  
2012 Intramural BADAL-SOLER, ANDREU CDRH Development, validation and dissemination of computational modeling tools to estimate radiation dose and image quality of emerging imaging technologies for the diagnosis and staging of breast cancer Oncology/cancer Predominantly affects women
2012 Intramural BADAL-SOLER, ANDREU CDRH Development, validation and dissemination of computational modeling tools to estimate radiation dose and image quality of emerging imaging technologies for the diagnosis and staging of breast cancer Medical device  
2012 Intramural BROWN, RONALD CDRH Sex differences in kidney biomarker response following exposure to an orthopedic alloy: Implications for the safety assessment of metal-on-metal hip implants Toxicology Sex differences
2012 Intramural BROWN, RONALD CDRH Sex differences in kidney biomarker response following exposure to an orthopedic alloy: Implications for the safety assessment of metal-on-metal hip implants Medical device  
2012 Intramural BROWN, RONALD CDRH Sex differences in kidney biomarker response following exposure to an orthopedic alloy: Implications for the safety assessment of metal-on-metal hip implants Biomarkers  
2012 Intramural FANG, LANYAN CDER Sex Disparities in Autoimmune Treatment Response Autoimmune Sex differences
2012 Intramural GOERING, PETER CDRH Safety and Efficacy of Iron Oxide Nanoparticles Used as MRI Contrast Agents for Breast Cancer Imaging Oncology/cancer Predominantly affects women
2012 Intramural GOERING, PETER CDRH Safety and Efficacy of Iron Oxide Nanoparticles Used as MRI Contrast Agents for Breast Cancer Imaging Medical device  
2012 Intramural LIACHENKO, SERGUEI NCTR Gender differences in neuronal reward circuit activation by nicotine and tobacco smoke using magnetic resonance spectroscopy Neurology Sex differences
2012 Intramural LUO, ZHONGJUN CFSAN Exploring Potential Safety Issues of PPIs on Osteoporosis in Elderly Women Using the PPI Legacy Database Pharmaceuticals Only women
2012 Intramural LUO, ZHONGJUN CFSAN Exploring Potential Safety Issues of PPIs on Osteoporosis in Elderly Women Using the PPI Legacy Database Musculoskeletal  
2012 Intramural MORRISON, TINA CDRH Abdominal Aortic Aneurysms: analysis of patient Characteristics and Anatomy Related to EVAR treatment and outcomes- AAA CARE Cardiovascular Sex differences
2012 Intramural MORRISON, TINA CDRH Abdominal Aortic Aneurysms: analysis of patient Characteristics and Anatomy Related to EVAR treatment and outcomes- AAA CARE Medical device  
2012 Intramural MYERS, MEAGAN NCTR Quantitative oncomutation profile of triple negative breast cancer Oncology/cancer Predominantly affects women
2012 Intramural MYERS, MEAGAN NCTR Quantitative oncomutation profile of triple negative breast cancer Gene expression  
2012 Intramural NALLANI, SRIKANTH CDER Applications of Clinical Pharmacology Principles in Pharmacotherapy of Diseases in Pregnancy Obstetrics/Gynecology Only women
2012 Intramural NALLANI, SRIKANTH CDER Applications of Clinical Pharmacology Principles in Pharmacotherapy of Diseases in Pregnancy Pharmacology  
2012 Intramural OVANESOV, MIKHAIL CBER Improving safety of blood products administered during pregnancy Hematologic Only women
2012 Intramural OVANESOV, MIKHAIL CBER Improving safety of blood products administered during pregnancy Obstetrics/Gynecology  
2012 Intramural OVANESOV, MIKHAIL CBER Improving safety of blood products administered during pregnancy Immunology  
2012 Intramural PAREPALLY, JAGAN MOHAN CDER Gender effect on PK/PD of hypnotic drug: Driving impairment and dosing recommendations Neurology Sex differences
2012 Intramural PAREPALLY, JAGAN MOHAN CDER Gender effect on PK/PD of hypnotic drug: Driving impairment and dosing recommendations Pharmacology  
2012 Intramural PAREPALLY, JAGAN MOHAN CDER Gender effect on PK/PD of hypnotic drug: Driving impairment and dosing recommendations Pharmaceuticals  
2012 Intramural RAGHEB, JACK CDER A Mechanistic Study of the Capacity of Silicone to Present (Self) Antigens to the Immune System Autoimmune Predominantly affects women
2012 Intramural RAGHEB, JACK CDER A Mechanistic Study of the Capacity of Silicone to Present (Self) Antigens to the Immune System Medical device  
2012 Intramural SHI, QIANG NCTR Identifying drugs that cause women-biased hepatotoxicity by reviewing FDA drug approcal packages/labels and FDA maintained databases and conducting comparitive studies in primary hepatocytes of rats, mice, and humans Hepatic Sex differences
2012 Intramural SHI, QIANG NCTR Identifying drugs that cause women-biased hepatotoxicity by reviewing FDA drug approcal packages/labels and FDA maintained databases and conducting comparitive studies in primary hepatocytes of rats, mice, and humans Pharmaceuticals  
2012 Intramural STRAUSS, DAVID CDRH Novel Electrocardiographic Biomarkers to Assess Cardiac Safety of Investigational Drugs Cardiovascular Sex differences
2012 Intramural STRAUSS, DAVID CDRH Novel Electrocardiographic Biomarkers to Assess Cardiac Safety of Investigational Drugs Biomarkers  
2012 Intramural STRAUSS, DAVID CDRH Gender-Specific Predictors of Heart Failure Hospitalization and Death in Cardiac Resynchronization Therapy Cardiovascular Sex differences
2012 Intramural STRAUSS, DAVID CDRH Gender-Specific Predictors of Heart Failure Hospitalization and Death in Cardiac Resynchronization Therapy Medical device  
2012 Intramural WU, WEN JIN CDER Investigating the molecular mechanisms of trastuzumab-induced cardiotoxicity and explore the cardioprotective role of antioxidants in the trastuzumab-mediated cardiac dysfunction Oncology/cancer Predominantly affects women
2012 Intramural WU, WEN JIN CDER Investigating the molecular mechanisms of trastuzumab-induced cardiotoxicity and explore the cardioprotective role of antioxidants in the trastuzumab-mediated cardiac dysfunction Toxicology  
2012 Intramural XIE, HANG CBER 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 influenza Infectious disease Sex differences
2012 Intramural XIE, HANG CBER 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 influenza Obstetrics/Gynecology  
2012 Intramural XIE, HANG CBER 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 influenza Immunology  
2012 Intramural YELLELA, SRI RAMA KRISHNAIAH CDER Quantification of drug retained in the skin after removal of estradiol transdermal drug delivery systems used in hormone replacement therapy Obstetrics/Gynecology Only women
2012 Intramural YELLELA, SRI RAMA KRISHNAIAH CDER Quantification of drug retained in the skin after removal of estradiol transdermal drug delivery systems used in hormone replacement therapy Medical device  
2012 Intramural YELLELA, SRI RAMA CDER Quantification of drug retained in the skin after removal of estradiol transdermal drug delivery systems used in hormone replacement therapy Pharmaceuticals  
2012 Intramural YELLELA, SRI RAMA KRISHNAIAH CDER Quantification of drug retained in the skin after removal of estradiol transdermal drug delivery systems used in hormone replacement therapy Dermatology  
2012 Intramural YU, CHONGWOO CDER Investigation of Drug-Drug Interactions with Hormonal Contraceptives Obstetrics/Gynecology  
2012 Intramural YU, CHONGWOO CDER Investigation of Drug-Drug Interactions with Hormonal Contraceptives Pharmacology  

Related links

 
Back to Top