Ellen E. Pinnow - Center for Drug Evaluation and Research, U.S. Food and Drug Administration

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Sources of Evidence Triggering and Supporting Safety-Related Labeling Changes: A 10-Year Longitudinal Assessment of 22 New Molecular Entities Approved in 2008 by the US Food and Drug Administration

David Croteau,Ellen Pinnow,Eileen Wu,Monica Muñoz,Ilynn Bulatao,Gerald Dal Pan

DRUG SAFETY（2022）

引用7浏览0WOS引用

The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes

Sanae Cherkaoui,Ellen Pinnow,Ilynn Bulatao,Brendan Day,Manish Kalaria,Sonja Brajovic,Gerald Dal Pan

CLINICAL PHARMACOLOGY & THERAPEUTICSno. 6 (2021): 1512-1525

引用2浏览0WOS引用

FDA postmarketing safety labeling changes: What have we learned since 2010 about impacts on prescribing rates, drug utilization, and treatment outcomes

Matthew Rosenberg,Sarah Sheehan,Esther Zhou,Ellen Pinnow, Jessica Burnell,Morgan Romine,Gerald Dal Pan

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY（2020）

引用2浏览0WOS引用

Postmarketing Safety-Related Regulatory Actions For New Therapeutic Biologics Approved In The United States 2002-2014: Similarities And Differences With New Molecular Entities

Ilynn Bulatao,Ellen Pinnow,Brendan Day,Sanae Cherkaoui,Manish Kalaria,Sonja Brajovic,Gerald Dal Pan

CLINICAL PHARMACOLOGY & THERAPEUTICSno. 6 (2020): 1243-1253

引用11浏览0WOS引用

A systematic assessment of key design and performance characteristics of drug exposure registries requested by the U.S. Food and Drug Administration

Yanling Zhao,Ellen Pinnow,Jacqueline M Major

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY（2018）

引用2浏览0WOS引用

Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014

Ellen Pinnow,Sania Amr,Søren M Bentzen,Sonja Brajovic,Laura Hungerford,Diane Marie St George,Gerald Dal Pan

CLINICAL PHARMACOLOGY & THERAPEUTICSno. 2.0 (2018): 390-400

引用35浏览0WOS引用

Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions

S Sekine,Ee Pinnow, E Wu, R Kurtzig, M Hall, Gj Dal Pan

CLINICAL PHARMACOLOGY & THERAPEUTICSno. 1 (2016): 102-108

引用9浏览0WOS引用

Impact of Scheduled Post-Marketing Safety Summary Analyses on Regulatory Actions

Shohko Sekine,Ellen E. Pinnow, Rebecca Kurtzig,Eileen Wu,Hall Marni,Gerald Dal Pan

PHARMACOEPIDEMIOLOGY AND DRUG SAFETYno. SUPnan (2015): 443-444

引用0浏览0引用

Enrollment and monitoring of women in post-approval studies for medical devices mandated by the Food and Drug Administration

Ellen Pinnow,Naomi Herz,Nilsa Loyo-Berrios,Michelle Tarver

JOURNAL OF WOMENS HEALTH（2014）

引用14浏览0WOS引用

Increasing participation of women in early phase clinical trials approved by the FDA

Ellen Pinnow,Pellavi Sharma,Ameeta Parekh,Natalie Gevorkian,Kathleen Uhl

Women's Health Issues（2009）

引用63浏览0WOS引用

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