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Author Details

Ann W McMahon
Center for Drug Evaluation and Research
2005
35
15
PMIDPaper TitleJournal TitlePublished Year
35968821Extrapolation of Adult Efficacy Data to Pediatric Systemic Lupus Erythematosus: Evaluating Similarities in Exposure-Response.J Clin Pharmacol2023
34090699Methodologic approaches in studies using real-world data (RWD) to measure pediatric safety and effectiveness of vaccines administered to pregnant women: A scoping review.Vaccine2021
34251405Summary of Literature on Pediatric Real-world Evidence and Effectiveness.JAMA Pediatr2021
34185899Drug Safety in Labeling for Pediatric Drug Development and Dose Selection in Submissions to the US Food and Drug Administration.J Clin Pharmacol2021
32112359Real-World Evidence to Assess Medication Safety or Effectiveness in Children: Systematic Review.Drugs Real World Outcomes2020
31937606Big Data in the Assessment of Pediatric Medication Safety.Pediatrics2020
32037154Acute Kidney Injury During Treatment with Intravenous Acyclovir for Suspected or Confirmed Neonatal Herpes Simplex Virus Infection.J Pediatr2020
32813442Methodologic approaches in studies using real-world data to measure pediatric safety and effectiveness of vaccines administered to pregnant women: a scoping review protocol.JBI Evid Synth2020
30452504Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration.JAMA Pediatr2019
30484072Serious Adverse Events Associated with Off-Label Use of Azithromycin or Fentanyl in Children in Intensive Care Units: A Retrospective Chart Review.Paediatr Drugs2019
29874532Assessing Drug Safety in Children - The Role of Real-World Data.N Engl J Med2018
28028203Development of a Pediatric Adverse Events Terminology.Pediatrics2017
28924994Workshop on evaluation of pediatric long-term neurocognitive development and medical products.Pharmacoepidemiol Drug Saf2017
27910218Octreotide use and safety in infants with hyperinsulinism.Pharmacoepidemiol Drug Saf2017
26687996Pediatric registries at the Food and Drug Administration: design aspects that increase their likelihood of success.Pharmacoepidemiol Drug Saf2016
27774353Stratification, Hypothesis Testing, and Clinical Trial Simulation in Pediatric Drug Development.Ther Innov Regul Sci2016
25968047Safety of octreotide in hospitalized infants.Early Hum Dev2015
26098297Pediatric post-marketing safety systems in North America: assessment of the current status.Pharmacoepidemiol Drug Saf2015
25287454Adherence to guidelines for glucose assessment in starting second-generation antipsychotics.Pediatrics2014
22711728Trends of outpatient prescription drug utilization in US children, 2002-2010.Pediatrics2012
23067905Pediatric cardiovascular safety: challenges in drug and device development and clinical application.Am Heart J2012
21042229Adverse Events Following Trivalent Inactivated Influenza Vaccination in Children: Analysis of the Vaccine Adverse Event Reporting System.Pediatr Infect Dis J2011
22025595Age and risks of FDA-approved long-acting β⿿-adrenergic receptor agonists.Pediatrics2011
20661880Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008.Pharmacoepidemiol Drug Saf2010
20506368Tumor necrosis factor alpha blockers and malignancy in children: forty-eight cases reported to the Food and Drug Administration.Arthritis Rheum2010
19450636Serious adverse events rarely reported after trivalent inactivated influenza vaccine (TIV) in children 6-23 months of age.Vaccine2009
18093701Inactivated influenza vaccine (IIV) in children <2 years of age: examination of selected adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) after thimerosal-free or thimerosal-containing vaccine.Vaccine2008
19052120Outbreak of adverse reactions associated with contaminated heparin.N Engl J Med2008
17240001Neurologic disease associated with 17D-204 yellow fever vaccination: a report of 15 cases.Vaccine2007
17540484Progressive vaccinia as an adverse event following exposure to vaccinia virus: case definition and guidelines of data collection, analysis, and presentation of immunization safety data.Vaccine2007
17154344Comparison of military and civilian reporting rates for smallpox vaccine adverse events.Pharmacoepidemiol Drug Saf2007
16517033Passive surveillance for generalized vaccinia in the United States using the Vaccine Adverse Event Reporting System (VAERS).Vaccine2006
16817805Correlates of public health workforce acceptance of smallpox immunization in Virginia.Public Health Nurs2006
15687455Adverse events after inactivated influenza vaccination among children less than 2 years of age: analysis of reports from the vaccine adverse event reporting system, 1990-2003.Pediatrics2005
15629350Photophobia following smallpox vaccination.Vaccine2005
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Collaborators

Robert Ball
Center for Drug Evaluation and Research
Co-authored papers 8
Dianne Murphy
Co-authored papers 5
Bruce C Carleton
BC Children's Hospital Research Institute
Co-authored papers 2
Mark A Turner
Institute of Translational Medicine, University of Liverpool
Co-authored papers 2
Gerald J Dal Pan
Center for Drug Evaluation and Research
Co-authored papers 2
Sara L Van Driest
National Institutes of Health
Co-authored papers 2
Robert M Califf
From the National Institutes of Health
Co-authored papers 1
Kathryn M Edwards
Vanderbilt University Medical Center
Co-authored papers 1
Victoria L Vetter
Perelman School of Medicine at the University of Pennsylvania
Co-authored papers 1
Mark A Hoffman
Children's Mercy Hospital
Co-authored papers 1
Robert B Penfold
Kaiser Permanente Washington Health Research Institute (C Hsu and RB Penfold)
Co-authored papers 1
Finale Doshi-Velez
Harvard University
Co-authored papers 1
Isaac S Kohane
Harvard Medical School
Co-authored papers 1
Jeffrey S Brown
Harvard Medical School and Harvard Pilgrim Health Care Institute
Co-authored papers 1
Margaret W Haber
National Cancer Institute
Co-authored papers 1
Michiyo Sakiyama
the Lifestyle Related Disease Medical Center
Co-authored papers 1
Amanda Hicks
Johns Hopkins University
Co-authored papers 1
Reese H Clark
Pediatrix Center for Research Education
Co-authored papers 1
Debbie S Gipson
University of Michigan ann arbor
Co-authored papers 1
Shohko Sekine
School of Pharmacy, Tokyo University of Pharmacy and Life Sciences
Co-authored papers 1
Christopher S Almond
Stanford University School of Medicine
Co-authored papers 1
William O Cooper
Vanderbilt University School of Medicine
Co-authored papers 1
Miriam C J M Sturkenboom
University Medical Center Utrecht
Co-authored papers 1
Norman Stockbridge
Center for Drug Evaluation and Research
Co-authored papers 1
K F Austen
Brigham & Women's Hospital
Co-authored papers 1
Anne M Dubin
Stanford University
Co-authored papers 1
Rishikesan Kamaleswaran
Duke University, Emory University, Society for Critical Care Medicine, University of Ontario Institute of Technology, University of Tennessee Health Science Center
Co-authored papers 1
Robert Langer
Co-authored papers 1
Robert L Davis
University of Tennessee Health Science Center
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Jennifer L Goldman
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Release 1.2