OWH Staff Publications
2021
Journal (commentary):
Vasisht KP, Nugent BM, Woodcock J. Progress and opportunities for women in clinical trials: A look at recent data and initiatives from the US FDA. Med. 2021; 2:456-504.
Journal (full paper):
Duggal M, Sacks L, Vasisht, KP (2021) Eligibility criteria and clinical trials: an FDA perspective. Contemporary Clinical Trials, 109: 106515
Jenkins MR, Munoz MA, Bak D, Chai G, Ready T, South EM, Zinn RL, Zusterzeel R, Woodcock J. Food and Drug Administration Beyond the 2001 Government Accountability Office Report: Promoting Drug Safety for Women. J Womens Health. 2021 Jul;30(7):927-934.
Nugent BM, Madabushi R, Buch B, Peiris V, Crentsil V, Miller VM, Bull J, Jenkins MR (2021) Heterogeneity in treatment effects across diverse populations. Pharmaceutical Statistics, 20(5):929-938.
2020
Journal (full paper):
South EM, Zinn RL, Huang CJ, Vasisht KP. US food and drug administration office of women's health: promoting therapeutic optimization in women. J Clin Pharmacol. 2020 Dec;60:S11-S17.
2019
Journal (full paper):
Ross JS, Rohde S, Sangaralingham L, Brito JP, Choi L, Dutcher SK, Graham DJ, Jenkins MR, Lipska KJ, Mendoza M, Qiang Y, Wang Z, Wu Y, Yao X, Shah ND. Generic and Brand-Name Thyroid Hormone Drug Use Among Commercially Insured and Medicare Beneficiaries, 2007 Through 2016. J Clin Endo Metab. 2019; 104:2305-2314.
Ayuso E, Geller RJ, Wang J, Whyte J, Jenkins M. Evaluation of Worldwide Clinical Trials by Gender: an FDA Perspective. Con Clin Trials. 2019; 80:16-21.
2018
Journal (full paper):
Scott P, Unger E, Jenkins M et al. Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs. J Am Coll Cardiol. 2018; 71:1960-1969
2016
Journal (full paper):
Elahi M, Eshera N, Bambata, N, et al. The Food and Drug Administration Office of Women’s Health: Impact of Science on Regulatory Policy: An Update. J Women's Health. February 2016, ahead of print. doi:10.1089/jwh.2015.5671.
2015
Journal (full paper):
Hansen C, Andrade SE, Freiman H, et al. Trimethoprim-sulfonamide use during the first trimester of pregnancy and the risk of congenital anomalies. Pharmacoepidemiol Drug Saf. 2015 Nov 24. doi: 10.1002/pds.3919. [Epub ahead of print] PubMed PMID: 26599424
Struble E, Fadiran E, Soule L. Thrombosis during pregnancy: Risks, prevention, and treatment for mother and fetus. Birth defects research part c: Embryo today: Reviews. September 2015; 105(3):157-158.
Eshera N, Itana H, Zhang L, et al. Demographics of Study Participants in Pivotal Clinical Trials for New Molecular Entity Drugs and Biologics Approved by FDA from 2010 to 2012. Am J Ther. 2015 Nov-Dec;22 (6):435-55.
Book Chapter:
Fadiran EO and Zhang L. (2015). Effects of Sex Differences in the Pharmacokinetics of drugs and Their Impact on the Safety of Medicines in Women in Medicines for Women, Mira Harrison Woolrych (Ed), Springer International Publishing Switzerland.
2013
Journal (full paper):
Rita Poon, Keshav Khanijow, Sphoorti Umarjee, Emmanuel Fadiran, Monica Yu, Lei Zhang, and Ameeta Parekh.
Participation of Women and Sex Analyses in Late-Phase Clinical Trials of New Molecular Entity Drugs and Biologics Approved by the FDA in 2007–2009. Journal of Women’s Health 2013; 22(7): 604-616
Hess CN, Rao SV, Kong DF, Miller JM, Anstrom KJ, Bertrand OF, Collet JP, Effron MB, Eloff BC, Fadiran EO, Farb A, Gilchrist IC, Holmes DR, Jacobs AK, Kaul P, Newby LK, Rutledge DR, Tavris DR, Tsai TT, White RM, Peterson ED, Krucoff MW
TransRadial Education And Therapeutics (TREAT): Shifting the balance of safety and efficacy of antithrombotic agents in percutaneous coronary intervention: A report from the Cardiac Safety Research Consortium.
Am Heart J. 2013;165(3):344-353
Journal (abstract):
Noha Eshera, Amber Marsh, Leslie Chinn, Lei Zhang, Emmanuel Fadiran.
Demographics of Study Participants in Clinical Trials for Cardiovascular Drugs Approved by FDA from 2010 to 2011
JACC Cardiovascular Interventions 2013; 6(2) (Suppl S), S37.
Magazine Article:
Gallauresi B, Kallgren D, Thomas K,
Taking Prescription Medicines, Healthy Mom & Baby, p39, Issue 11, Spring 2013.
2012
Journal (full paper):
D Tavris, Y Wang, S Jacobs, B Gallauresi, J Curtis, J Messenger, F Resnic, S Fitzgerald
Bleeding and Vascular Complications at the Femoral Access Site Following Percutaneous Coronary Intervention (PCI): An Evaluation of Hemostasis Strategies
J Invasive Cardiol, 2012; 24(7):328-334
B Gallauresi
Information for Pregnant Women & Prescription Drugs: The Food and Drug Administration Office of Women’s Health Pregnancy Exposure Registry Website
National Black Nurses Association News, Winter 2012, pg 31
M Coakley, E Fadiran, LJ Parrish, RA Griffith, E Weiss, C Carter.
Dialogues on diversifying clinical trials: successful strategies for engaging women and minorities in clinical trials.
J Women’s Health, Jul 2012, 21(7):713-6
Journal (abstract):
O Otugo, O Ogundare, C Vaughan, E Fadiran, L Sahin.
The Consistency of Pregnancy Labeling Across Different Therapeutic Classes
J of Women’s Health 2012
Poster presented at Women’s Health 2012 Congress.
O Otugo, R Poon, V Copeland, K Khanijow, S Umarjee, L Chinn, E Fadiran, L Zhang, A Parekh.
Survey of the Presentation of Sex Analysis in the FDA Review of Efficacy and Safety of New Molecular Entity Drugs and Biologics approved from 2007 to 2009
Clin Pharm Ther 2012; 91(Supp 1), S97-98 (Abstract # PIII-4).
Poster presentation at American Society of Clinical Pharmacology & Therapeutics (ASCPT) 2012.
L Chinn, R Poon, E Fadiran, A Parekh, S Huang, L Zhang.
Comparison of Inclusion of Women in Early versus Late Phase Clinical Trials in Recently US FDA-Approved New Drug and Biologics Applications
Clin Pharm Ther 2012; 91(Supp 1), S97 (Abstract # PIII-2).
Poster presentation at ASCPT 2012.
D Dave, B Gallauresi
Representation of Females and Racial/Ethnic Subgroups in FDA Approved Orthopedic Medical Devices: A Ten Year Review
Organization for the Study of Sex Differences (OSSD) annual meeting proceeding, June, 2012.
Poster presented at OSSD, 6/2012
D Dave, J Brown, B Gallauresi.
An FDA ten year review of clinical trails for approved medical devices for women
J of Women’s Health 2012
Poster presented at The Women’s Health 2012 Congress.
2011
Book Chapter:
A. Parekh
Chapter: Women in Clinical Trials US-FDA Regulatory Perspective
Text: Handbook of Gender Medicine
A. Parekh
Chapter: Women in Clinical Drug Trials: US-FDA Update on Policies and Practices
Book: Institute of Medicine of the National Academies
D Tavris, B Gallauresi
Chapter: Hemostasis Devices
Book: Coronary Interventions
Journal (full paper):
J. Florian, C. Tornøe, R. Brundage, A. Parekh, C. Garnett
Population Pharmacokinetic and Concentration-QTc Models for Moxifloxacin: Pooled Analysis of 20 Thorough QT Studies
J Clin Phar, Jan 2011; 51:1152-1162.
D Haas, B Gallauresi, K Shields, D Zeitlin, S Clark, M Hebert, Z Ren, S Nallani, E Meslin, K Feibus, G Koren, S Goebel, T Easterling, S Denne, D Flockhart, J Renbarger
Manuscript: Pharmacotherapy and Pregnancy: Highlights from the Third International Conference for Individualized Pharmacotherapy in Pregnancy
Clin and Translational Science, 2011; 4(3):204-209
A. Parekh, E. Fadiran, K. Uhl, Throckmorton, D
Adverse Effects in Women: Implications for Drug Development and Regulatory Policies
Expert Reviews Clinical Pharmacology, 2011; 4(4):453-466
Journal (abstract):
M. Pazirandeh, E. Fadiran, B. Gallauresi, A. Parekh
FDA Office of Women’s Health Funded Breast Cancer Studies – 1994-2010
J of Women’s Health 2011
V. Copeland, M. Yu, E. Fadiran, A. Parekh
Review of HIV Funded Studies by the FDA Office of Women’s Health (OWH)
J of Women’s Health 2011
Poster presented at the Women’s Health 2011 Congress, April 2011
R. Poon, K. Khanijow, S. Umarjee, E. Fadiran, M. Yu, L. Zhang, A. Parekh
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
J of Women’s Health 2011
Poster presented at the Women’s Health 2011 Congress, April 2011
V. Copeland, A. Parekh
FDA Approved Drug Labels 2007-10: Dose Adjustments for Women Based on Exposure
Drug Information Association (DIA)
Poster presented at DIA June 2011
R. Poon, K. Khanijow, S. Umarjee, E. Fadiran, M. Yu, L. Zhang, A. Parekh
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
Drug Information Association (DIA)
Poster presented at DIA June 2011
O. Laiyemo, A. Parekh, E. Fadiran, M. Yu, B. Gallauresi.
FDA Office of Women’s Health Funded Extramural Pregnancy and Lactation Related Studies: 2001 – 2008
Organization for the Study of Sex Differences (OSSD)
Poster presented at OSSD, 6/2011
2010
Journal (full paper):
S. Goldkind, L Sahin, B. Gallauresi
Enrolling pregnant women in research: lessons learned from the HINI pandemic
New Eng J Med 2010; 362:2241-43
Journal (abstract):
T Nguyen, E Fadiran, A Parekh
Review of oncology studies funded by the FDA Office of Women’s Health – 1994-2007
AAPS J. 2010; 10(S2), No 3453
Poster presented at the American Association of Pharmaceutical Scientists (AAPS) 2010 annual meeting
M. Yu, A. Parekh, E. Fadiran, B. Gallauresi, S. Lemtouni, K. Khanijow, S. Umarjee, L. DiPaola
FDA Office of Women’s Health Funded Biological Studies: 1994-2009, a summary report
AAPS J. 2010; 10(S2), No 4436
Poster presented at AAPS 2010 annual meeting
S.Umarjee, S. Lemtouni, E. Fadiran, A. Parekh
Patient demographics in cardiovascular drug trials: FDA reviews from 2007 to 2008
Clin Pharm Ther 2010; 87(supp 1), S75, No. PIII-23
Poster presented at the American Society of Clinical Pharmacology & Therapeutics (ASCPT) 2010 annual meeting
E Fadiran, A Parekh, K Uhl
The Science of Sex Differences in the Pharmacokinetics and Pharmacodynamics of Drugs - Case studies
Clin Pharm Ther 2010; 87(supp 1), S93, No PIII-80
Poster presented at ASCPT 2010 annual meeting
C Kolajo, E Fadiran, S Lemtouni, A Parekh
Cardiovascular Studies Funded by Food and Drug Administration Office of Women’s Health - 1994-2009
J of Women’s Health 2010; 19(3):612, No 25
Bulletin:
B. Gallauresi
FDA’s Pregnancy Exposure Registry website. J of Women’s Health, June 2010
K. Khanijow
Status of Women’s Participation in Clinical Trials. J of Women’s Health, October 2010
2009
Book Chapter:
D. Fleisher, B. Sweet, A. Parekh
Chapter: Drug Absorption with Food
Section: Influence of Food or Nutrients on Drug Disposition and Effect
Text: Handbook of Drug-Nutrient Interactions, 2nd Edition
Journal (full paper):
J. Finkle, D. Bloomfield, K. Uhl, W. Sanhai, N. Stockbridge, M. Krucoff
Cardiac Safety Research Consortium Conference Papers: New precompetitive paradigms: Focus on cardiac safety
Am Heart J 2009; 157(5): 827-836
E Pinnow, P. Sharma, A. Parekh, N. Gevorkian, K. Uhl
Increasing Participation of Women in Early Phase Clinical Trials Approved by the FDA
Women’s Health Issues 2009; 19(2):89-93
KL Wisner, PS Appelbaum, K Uhl, SF Goldkind
Pharmacotherapy for Depressed Pregnant Women: Overcoming Obstacles to Gathering Essential Data
Clin Pharm Ther 2009; 86(4):362–365
Presented at ASCPT 2009 annual meeting
Journal (abstract):
S. Umarjee, S. Lemtouni, E. Fadiran, A. Parekh
Enrollment of women in cardiovascular drug trials reviewed by FDA from 2007 to 2008
AAPS J 2009; 11(S2), No 3765
Poster presented AAPS 2009 annual meeting
S. Lemtouni, A. Defelice, K. Uhl, J. Willard
Enrollment of Women and Ethnic Minorities and their Drop-out Profiles: More than a Quarter of a Century Experience (1973-2001) in Antihypertensive Drug Trials
Circulation. 2009;120:S498-S499
Poster presented at the Am Heart Asso (AHA) 2009 annual meeting
2008
Journal (full paper):
P. Sharma, A. Parekh, K. Uhl
An Innovative Approach To Determine Fetal Risk, The FDA Office of Women’s Health Pregnancy Exposure Registry Web Listing 2007 Pregnancy Registry.
Women’s Health Issues 2008; 18:226-228
A Oliva, E Pinnow, R Levin, K Uhl
Improving Women’s Health through Modernization of Our Bioinformatics Infrastructure
Clin Phar Ther 2008; 83(1):192–195
S Andrade, M Raebel, J Brown, K Lane, J Livingston, D Boudreau, S Rolnick, D Roblin , D. Smith, G Dal Pan, P Scott, R Platt
Outpatient use of cardiovascular drugs during pregnancy
Pharmacoepidemiology and drug safety 2008; 17: 240–247
Journal (abstract):
N. Gevorkian, P. Sharma, E. Pinnow, A. Parekh
QT Prolongation Potential for New Molecular Entity Drugs approved by FDA, 2003-2006: Labeling Review
Clin Phar Ther 2008; 83, S44
Poster presented at the ASCPT 2008 annual meeting
E. Pinnow, A. Parekh, P. Sharma, N. Gevorkian, K. Uhl
Inclusion of Subpopulation in Early Phase Clinical Trials submitted to the FDA: A Review of NMES Approved 2006-2007
Clin Phar Ther 2008;83, S86-S87
Poster presented at the ASCPT 2008 annual meeting
2007
Journal (full paper):
D Obias-Manno, P Scott, J Kaczmarczyk, M Miller, E Pinnow, L Lee-Bishop, M Jones-London, K Chapman,
D Kallgren, K Uhl
The Food and Drug Administration Office of Women’s Health: Impact of Science on Regulatory Policy
J of Women’s Health 2007; 16(6):807-817
A. Parekh, W. Sanhai, S. Marts, K. Uhl
Advancing Women’s Health via FDA Critical Path Initiative
Drug Discovery Today: Technologies, Critical Path 2007; 4(2):69-73
K. Uhl, A. Parekh, S. Kweder
Females in Clinical Studies: Where are we going?
Clin Pharm Ther 2007; 81(4):600-602
1994 – 2005
Book Chapter:
SM Huang, M Miller, T Toigo, M Chen, C Sahajwalla, L Lesko, R Temple
Evaluation of Drugs in Women: Regulatory Perspective
Section 11, Drug Metabolism/Clinical Pharmacology (Section editor: Schwartz, J.; Legato, M (ed)) Principles of Gender-Specific Medicine, pp 848-859, Academic Press, 2004
Journal (full paper):
Susan Wood
Women’s Health and the FDA
New Eng J Med 2005; 353(16):1650-1651
B. Evelyn, T. Toigo, D. Banks, D. Pohl, K. Gray, B. Robins, and J. Ernat
Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling: A Review of New Molecular Entities Approved 1995-1999
J Nat Med Assoc. 2001; 93(12):18S-24S
M Miller
Gender-Based Differences in the Toxicity of Pharmaceuticals - The Food and Drug Administration’s Perspective
International J of Toxic 2001; 20:149–152
T Toigo
Hearing the cry for help and information
FDA Consumer 2001, p36
Susan Wood
Office of Women’s Health, Food and Drug Administration: Future Directions for Women’s Health
J of Am Med Women Assoc 2001; 56:197-198
M Martinez, L Friendlander, R Condon, J Meneses, J O’Rangers, N Webber, M Miller
Response to critisms of the US FDA parametric approach for withdrawal time estimation rebuttal and comparison to the nonparametric method proposed by Concordet and Toutain
J. Vet. Pharm Ther 2000; 23:21-35
L Poirier, D Doerge, D Gaylor, M Miller, R Lorentzen, D Casciano, F Kadlubar, B Schwetz
An FDA Review of Sulfamethazine Toxicity
Regulatory Toxic Pharm 1999; 30:217–222
L. Sherman, R. Temple, R. Merkatz
Women in Clinical Trials: An FDA Perspective
Science 1995; 269:793-795
R Merkatz, E Summers,T Toigo
FDA: Making a Difference for Women and HIV/AIDS
J of Am Med Women Assoc 1995; 50(3-4):108-120
Ruth Merkatz
FDA: Making a difference in Women’s Health
J of Am Med Women Assoc 1994; 49(4):117-21
Ruth Merkatz
Historical Background of Changes in FDA Policy on the Study and Evaluation of Drugs in Women
Academic Med 1994; 69(9):703-7