OWH Presentations and Publications

Through presentations, peer-reviewed publications, and book chapters, OWH staff and OWH-funded researchers are working to advance the science of sex differences and foster a greater understanding of FDA’s policies and initiatives in this area. Check one of the publications or presentations highlighted on this page to learn more about these efforts.

 

Publications

• OWH Staff Publications
• Publications from OWH-supported studies

 

Presentations

June 2012

• Poster: Representation of Females and Racial/Ethnic Subgroups in FDA Approved Orthopedic Medical Devices: A Ten Year Review.  D Dave, B Gallauresi. Organization for the Study of Sex Differences (OSSD) annual meeting, June 7-9, 2012, Baltimore, MD.
• Poster: Assessment of the Consistency of Pregnancy Labeling Across Therapeutic Classes.  O Otugo, J Chou, O Ogundare, C Vaughan, E Fadiran, L Sahin. Organization for the Study of Sex Differences (OSSD) annual meeting, June 7-9, 2012, Baltimore, MD.

 

May 2012

• Poster: Consistency of Pregnancy Labeling Across Therapeutic Class for the Top 20 Drugs (2010) by Sales. O Otugo, E Fadiran, L Sahin. American College of Obstetricians and Gynecologists (ACOG) Clinical Meeting, May 5-9, 2012, San Diego, CA.
• Poster:  An FDA ten year review of clinical trials for approved Obstetrics and Gynecological medical devices.  D Davé, J Brown, B Gallauresi.  (ACOG) Clinical Meeting, May 5-9, 2012, San Diego, CA. 
   

April 2012

• Poster: ¡Nunca Más! Novela Series: Teaching Hispanic Women about Safe Medication Use. Kimberly Thomas. National Hispanic Medical Association Annual Conference. April 27-28, 2012.

 

March 2012

• Poster: An FDA ten year review of clinical trails for approved medical devices for women.   D Dave, J Brown, B Gallauresi. Women's Health 2012: The 20th Annual Congress. March 16-18, 2012, Washington, DC.
• Poster: Consistency of Pregnancy Labeling Across Different Therapeutic Classes.             O Otugo, O Ogundare, C Vaughan, E Fadiran, L Sahin. Women’s Health 2012: The 20th Annual Congress. March 16-18 2012, Washington, DC.
• Poster: Survey of the Presentation of Sex Analysis in the FDA Review of Efficacy and Safety Clinical Data of New Molecular Entity Drugs and Biologics Approved from 2007 to 2009.                                                                                                                  O Otugo, R Poon, V Copeland, K Khanijow, S Umarjee, L Chinn, E Fadiran, L Zhang, A Parekh. American Society Clinical Pharmacology Therapeutics (ASCPT) Annual Meeting. March 14-17, 2012, National Harbor, MD.
• Panel: Women's Clinical Leadership Forum. Marsha Henderson. 21st Annual Partnerships in Clinical Trials Conference. March 4, 2012. Orlando, FL.

 

February 2012

• Panel: Health Forum: "Making Health Care Work for Our Communities". Marsha Henderson. Delta Days in the Nation's Capital. February 6, 2012, Washington, DC

 

November 2011

• Presentation: Pregnancy Exposure Registry website. Beverly Gallauersi.  2011 Illinois Women's Health Conference, November 2-3, 2011, Springfield, IL
• Presentation: Pregnancy Exposure Registry website. Beverly Gallauersi.  2011 Annual Meeting of the Association of Military Surgeons United States, (AMSUS), November 7-9, 2011, San Antonio, TX 
• Presentation: Reaching Out for Health Through Social Media. Alison Lemon. 2011 Latism National Conference, November 9-11, 2011, Chicago, IL
   

October 2011

• Poster: Using video novellas and plain language publications to educate Latino women about safe medication use. Deborah Kallgren and Kimberly A. Thomas. American Public Health Association Annual Meeting, October 31, 2011, Washington, DC.
• Poster: Sex-Differences in Exposure for FDA Approved New Molecular Entities (NMEs) 2007-2010: Exposure Based Dosing in Subgroup Populations. V Copeland, C Sahajwalla, A Parekh, 2011 American Association of Pharmaceutical Scientists annual meeting, Oct 23-27, 2011, Washington DC

 

September 2011

• Presentation: Participation in Drug Trials-US FDA Perspective- Ameeta Parekh,                 
  Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities Conference, Sept 23, 2011, Washington DC
• Presentation: Drug Safety – Is It Different For Men and Women? - Emmanuel Fadiran, American College of Clinical Pharmacology, 40th Annual Meeting, Sept 9 - 13, 2011, Chicago, IL 

 

August 2011

• Presentation: Sex-Specific reporting of scientific research -US FDA perspective, Ameeta Parekh. IOM sponsored workshop on Sex-Specific Reporting of Scientific Research,  August 30, 2011, Washington, DC
• Presentation: FDA Office of Women's Health Overview, Ameeta Parekh, 40th Anniversary National Center for Toxicological Research (NCTR), August 10, 2011, Little Rock, AK.
• Presentation: Regulatory Impact of Funded Research on Women's Health, Emmanuel Fadiran .40th Anniversary National Center for Toxicological Research (NCTR), August 10, 2011, Little Rock, AK

 

June 2011

• Presentation: FDA Office of Women’s Health Pregnancy Exposure Registry Website. B. Gallauresi, The American Academy of Nurse Practitioners Annual Meeting, June 24, 2011, Las Vegas, NV
• Presentation: HRSA’s Patient Safety and Clinical Services Collaborative - Karen C. Williams (HRSA) and Beverly Gallauresi (FDA) American Academy of Nurse Practitioners Annual Meeting, June 24, 2011, Las Vegas, NV
• Poster: Participation of Women and Sex Analyses in Late Phase Clinical Trials of New Molecular Entity (NME) Drugs and Biologics Approved by the FDA in 2007-2009. R Poon, K Khanijow, S Umarjee, E Fadiran, M Yu, L Zhang, A Parekh, Drug Information Association 2011 47th Annual Meeting, June 19-23, 2011, Chicago, IL
• Poster: FDA Approved Drug Labels 2007-10: Dose Adjustments for Women Based on Exposure. V Copeland, A Parekh, Drug Information Association 2011 47th Annual Meeting, June 19-23, 2011, Chicago, IL  
• Poster: FDA Office of Women’s Health Funded Biological Studies: 1994-2010. M. Yu, A. Parekh, E. Fadiran, R. Poon, V. Copeland, Organization for the Study of Sex Differences (OSSD) Fifth Annual Meeting, June 2-4, 2011, Oklahoma City, OK
• Poster: Women and ethnic minorities: a five year review of approved cardiovascular medical devices. Gallauresi, B; Khanijow, K; Umarjee, S; Parekh, A, OSSD Fifth Annual Meeting, June 2-4, 2011, Oklahoma City, OK
• Poster: FDA Office of Women’s Health Funded Extramural Pregnancy and Lactation Related Studies: 2001 – 2008. O. Laiyemo, A. Parekh, E. Fadiran, M. Yu, B. Gallauresi, OSSD Fifth Annual Meeting, June 2-4, 2011, Oklahoma City, OK
• Poster: Tracking Women’s Participation and Sex Analyses in Late Phase Clinical Trials of New Molecular Entity (NME) Drugs and Biologics Approved by the FDA between 2007 and 2009. R Poon, K Khanijow, S Umarjee, E Fadiran, M Yu, Lei Zhang, A Parekh, OSSD Fifth Annual Meeting, June 2-4, 2011, Oklahoma City, OK
• Poster: An Overview of HIV Funded Studies by the FDA Office of Women’s Health. V Copeland, M Yu, E Fadiran, A Parekh, OSSD Fifth Annual Meeting, June 2-4, 2011, Oklahoma City, OK

 

May 2011

• Presentation : "A Partner in Patient-Centered Care: Utilizing Resources from the FDA Office of Women's Health". Kimberly A. Thomas. HRSA Patient Safety and Clinical Pharmacy Services Collaborative (PSPC), Webcast - Learning Session #2, May 24, 2011.
• Presentation: Marsha Henderson. 9th International Symposium on Osteoporosis - "Translating Research into Clinical Practice", May 20, 2011, Las Vegas, NV.
• Presentation: Drug Exposures During Pregnancy - Role of Office of Women's Health, Ameeta Parekh, Pregnancy and Prescription Medication Use Symposium, FDA Office of Women’s Health, Silver Spring, MD, May 17, 2011 
                         

April 2011

• Poster: FDA Office of Women’s Health Funded Breast Cancer Studies - 1994-2010. Michael Pazirandeh, Emmanuel Fadiran, Beverly Gallauresi, Ameeta Parekh: Women’s Health 2011, April 1-3, 2011, Washington DC
• Poster: Participation of Women in Late Phase Clinical Trials of New Molecular Entity (NME) Drugs and Biologics Approved by the Food and Drug Administration between 2007 and 2009. Rita Poon, Keshav Khanijow, Sphoorti Umarjee, Emmanuel Fadiran, Monica Yu, Lei Zhang, Ameeta Parekh; Women’s Health 2011; April 1-3, 2011, Washington DC.
• Poster: Review of HIV Funded Studies by the FDA Office of Women's Health (OWH). Vanessa Copeland, Monica Yu, Emmanuel Fadiran, Ameeta Parekh; Women's Health 2011, April 1-3, 2011, Washington, DC

 

March 2011

• Poster: Educating African American and Hispanic Women about Mammography. Kimberly A. Thomas. Fourth Health Disparities Conference - Xavier University of Louisiana College of Pharmacy, March 27-29, 2011.
• Poster: Optimization of the Efficacy, Safety, and Risk/Benefit Review: Need for Early Integration of SDTM/ADaM Data Representations. A Szarfman, J Levine, CG Rochester, F Pucino, A Paredes, J Korvick,  E Fadiran, J Norton, JM Tonning, J Diefenbach : DIA/CDER/CBER Computational Science Annual Meeting, March 14-15, 2011, Arlington, VA
• Presentation: Bleeding, PCI and Women’s Health - Ameeta Parekh. TransRadial Education And Therapy (TREAT) II: A Cardiac Safety Critical Path Thinktank, March 7, 2011, FDA Headquarters - White Oak
• Presentation: Marsha Henderson. Delta Day at the United Nations - Empowering Women and Girls Globally. March 4, 2011, New York, NY
• Poster: A Five year review of approved cardiovascular medical devices: Are women and ethnic minorities adequately represented?Beverly Gallauresi, Keshav Khanijow, Sphoorti Umarjee, Ameeta Parekh. Cardiovascular Research Technologies (CRT) February 27–March 1, 2011, Washington, DC

 

February 2011

• Presentation: Marsha Henderson. Health Forum: "Making Health Care Work for Our Communities". Delta Days in the Nation's Capital 2011, February 7, 2011, Washington, DC  

 

November 2010

• Panel Discussion: Ethnic Sensitivity in PK/PD: Leveraging Clinical Development in Emerging Countries – Using Knowledge of Ethnic Differences to Facilitate Drug Development - Ameeta Parekh. American Association of Pharmaceutical Sciences Annual Meeting and FIP PSWC, November 18, 2010
• Poster: Review of Oncology Studies Funded by the FDA Office of Women’s Health – 1994-2007. Tien Nguyen, Emmanuel Fadiran, Ameeta Parekh, Joint FIP/AAPS Annual Meeting, November 14-18, 2010
• Poster: FDA Office of Women’s Health Funded Biological Studies: 1994-2009 - A Summary Report. Monica Yu, Ameeta Parekh, Emmanuel Fadiran, Beverly Gallauresi, Salma Lemtouni, Keshav Khanijow, Sphortee Umarjee, Lauren DiPaola, Joint FIP/AAPS Annual Meeting, November 14-18,

 

October 2010

• Presentation: The American Regulatory Perspective on Women in Clinical Trials - Ameeta Parekh. Karolinska Institute of Sweden, October 2010

 
September 2010

• Keynote Speaker: Marsha Henderson, Session - Caring Women: Things Mama Forgot to Mention. AARP life@50+ Conference, September 30, 2010
• Poster: Participation of Women in Clinical Trials: A Fifteen Year Assessment by the FDA Office of Women’s Health (OWH). Keshav Khanijow and Ameeta Parekh, Scientific Symposium: Celebrating the 20th Anniversary of the Office of Research on Women’s Health, NIH, September 27, 2010
• Poster: The Science of Sex Differences in the Pharmacokinetics and Pharmacodynamics of Drugs - Case studies. Emmanuel Fadiran, Ameeta Parekh, and Kathleen Uhl, Scientific Symposium: Celebrating the 20th Anniversary of the Office of Research on Women’s Health, NIH, September 27, 2010
• Presentation: FDA Office of Women’s Health Overview - Ameeta Parekh. NCTR Women’s Health Research Workshop on Sex Differences in FDA Regulated Products: Research for the Future, September 2, 2010
• Presentation: FDA Data Standardization Initiatives: Implications for Demographics Analysis - Emmanuel Fadarin. NCTR Women’s Health Research Workshop on Sex Differences in FDA Regulated Products: Research for the Future, September 2, 2010

 

July 2010

• Presentation: On Translating Science Into Regulatory Policy And Practices: The FDA View -Ameeta Parekh 22nd Annual Native Health Research Conference, July 28, 2010
• Presentation: Women's Faculty SIG Luncheon - Marsha Henderson. American Association of Colleges of Pharmacy Annual Meeting, July 11, 2010
• Presentation: Promoting Wellness For Yourself and Those Who Need You - Alison Lemon. National Alliance on Mental Illness Annual Conference, July 3, 2010

 
June 2010

• Presentation: FDA Office of Women’s Health Perspective - Beverly Gallauresi. Trans-radial Think Tank Meeting, June 23, 2010
• Presentation: FDA Office of Women’s Health Pregnancy Exposure Registry Website - Beverly Gallauresi. American College of Nurse Midwives Annual Conference, June 14-15, 2010
• Presentation: Supporting Nurse Midwives: Strengthening Women's Health - Susana Perry. American College of Nurse Midwives Annual Conference, June 14-15, 2010
• Poster: Using New Media to Deliver Health Information: A Twitter Pilot Project. Alison Lemon, Social Marketing in Public Health Conference, June 11-12, 2010
• Presentation: An overview of the FDA Office of Women’s Health (OWH) funded Pregnancy studies and their impact - Beverly Gallauresi.Third International Conference for Individualized Pharmacotherapy in Pregnancy, June 7, 2010
• Poster: FDA Office of Women’s Health Funded Studies on Medical Devices and Diagnostic Tests and Impact on Women’s Health- 1994-2009. Christopher Sheard, Emmanuel Fadiran, Ameeta Parekh, OSSD Annual Meeting, June 3-5, 2010

 

March 2010

• Poster: Participation of Women in Clinical Trials:  A fifteen year assessment by the FDA Office of Women’s Health (OWH). Keshav Khanijow, Ameeta Parekh, Women’s Health 2010:  The 18th Annual Congress, March 26-28, 2010
• Poster: FDA Office of Women’s Health Funded Oncology Studies - 1994-2009. Tien Nguyen, Emmanuel Fadiran, Ameeta Parekh, Women’s Health 2010: The 18th Annual Congress, March 26-28, 2010
• Poster: The Patient Safety and Clinical Pharmacy Services Collaborative. Susana Perry, Krista Pedley (HRSA), Women’s Health 2010: The 18th Annual Congress, March 26-28, 2010
• Poster: FDA Office of Women’s Health Intramural Funded Studies on Women’s Cardiovascular Health -1994-2009. Christianah Kolajo, Emmanuel Fadiran, Salma Lemtouni, Ameeta Parekh, Women’s Health 2010: The 18th Annual Congress, March 26-28, 2010
• Poster: The Science of Sex Differences in the Pharmacokinetics and Pharmacodynamics of Drugs - Case Studies. Emmanuel O. Fadiran, Ameeta Parekh and Kathleen Uhl, ASCPT 2010, March 17-20, 2010
• Presentation: Women’s Participation in Clinical Trials:  A Regulatory View - Ameeta Parekh. IOM Forum on Neuroscience and Nervous System Disorders, March 8-9, 2010
• Poster: Information regarding the Pregnancy Exposure Registry Website. Beverly Gallauresi, Lauren DiPaola, Ameeta Parekh, Kathleen Uhl, Association of Maternal Child and Health Programs, March 6-10, 2010

 

February 2010

• Poster: A review of recently approved cardiovascular medical devices: Are females adequately represented? Beverly Gallauresi; Sphoorti Umarjee; Keshav Khanijow; Ameeta Parekh; Kathleen Uhl, CRT 2010, February 21-23, 2010
• Poster: Cardiovascular Studies Funded by Food and Drug Administration Office of Women’s Health - 1994-2009. Christianah Kolajo, Emmanuel Fadiran, Salma Lemtouni, Ameeta Parekh, CRT 2010, February 21-23, 2010
• Poster: “It’s not what you say, it’s how you say it”: Promoting Public Health through Health Communication Materials from the FDA Office of Women’s Health. Alison Dingwall, American Academy of Health Behavior, February 7, 2010