Ellen Pinnow

Affiliations

Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Publications (9)

A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs.

Drug safety

Avec: Ameet Sarpatwari , Mayookha Mitra-Majumdar , Katsiaryna Bykov , Jerry Avorn , Steven Woloshin , Gita A Toyserkani , Cynthia LaCivita , Claudia Manzo , Esther H Zhou , Ellen Pinnow , Gerald J Dal Pan , Joshua J Gagne , Krista F Huybrechts , William B Feldman , Kristyn Chin , Aaron S Kesselheim

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

Pharmacoepidemiology and drug safety

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

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

Clinical pharmacology and therapeutics

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

Postmarketing Safety-Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002-2014: Similarities and Differences With New Molecular Entities.

Clinical pharmacology and therapeutics

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

Trend changes of national zolpidem users and exposure cases after FDA drug safety communications.

Pharmacoepidemiology and drug safety

Avec: Esther H Zhou , Zhou Feng , Ellen Pinnow , Joann Lee , Daniel Bak , Travis Ready , Gerald J Dal Pan

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.

Drug safety

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

Assessment of the Impact of Mandated Postmarketing Pediatric-Focused Safety Reviews on Safety-Related Regulatory Actions 2013-2019.

Clinical pharmacology and therapeutics

Avec: Mohamed Mohamoud , Carmen Cheng , Debra Ryan , Ivone Kim , Eileen Wu , Monica Muñoz , Cindy Kortepeter , Ellen Pinnow , Gerald Dal Pan

Trends in pediatric nonprescription analgesic/antipyretic exposures during the COVID-19 pandemic.

Clinical toxicology (Philadelphia, Pa.)

Avec: Sara Karami , Cooma Asonye , Ellen Pinnow , Valerie Pratt , Lynda McCulley , Nana Dwumfour , Esther H Zhou

Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling.

Drug safety

Avec: George A Neyarapally , Leihong Wu , Joshua Xu , Esther H Zhou , Oanh Dang , Joann Lee , Dharmang Mehta , Rochelle D Vaughn , Ellen Pinnow , Hong Fang

Réseau de co-auteurs

Gerald Dal Pan 5 collaborations

Esther H Zhou 4 collaborations

Ilynn Bulatao 3 collaborations

Gerald J Dal Pan 2 collaborations

Sanae Cherkaoui 2 collaborations

Brendan Day 2 collaborations

Manish Kalaria 2 collaborations

Sonja Brajovic 2 collaborations

Joann Lee 2 collaborations

Eileen Wu 2 collaborations

Monica Muñoz 2 collaborations

Ameet Sarpatwari 1 collaboration

Mayookha Mitra-Majumdar 1 collaboration

Katsiaryna Bykov 1 collaboration

Jerry Avorn 1 collaboration

Steven Woloshin 1 collaboration

Gita A Toyserkani 1 collaboration

Cynthia LaCivita 1 collaboration

Claudia Manzo 1 collaboration

Joshua J Gagne 1 collaboration

Krista F Huybrechts 1 collaboration

William B Feldman 1 collaboration

Kristyn Chin 1 collaboration

Aaron S Kesselheim 1 collaboration

Matthew Rosenberg 1 collaboration

Sarah Sheehan 1 collaboration

Esther Zhou 1 collaboration

Jessica Burnell 1 collaboration

Morgan Romine 1 collaboration

Zhou Feng 1 collaboration

Daniel Bak 1 collaboration

Travis Ready 1 collaboration

David Croteau 1 collaboration

Mohamed Mohamoud 1 collaboration

Carmen Cheng 1 collaboration

Debra Ryan 1 collaboration

Ivone Kim 1 collaboration

Cindy Kortepeter 1 collaboration

Sara Karami 1 collaboration

Cooma Asonye 1 collaboration

Valerie Pratt 1 collaboration

Lynda McCulley 1 collaboration

Nana Dwumfour 1 collaboration

George A Neyarapally 1 collaboration

Leihong Wu 1 collaboration

Joshua Xu 1 collaboration

Oanh Dang 1 collaboration

Dharmang Mehta 1 collaboration

Rochelle D Vaughn 1 collaboration

Hong Fang 1 collaboration