Scientific Publications by FDA Staff

Recent Scientific Publications: Office of the Commissioner

• J Law Med Ethics 2013 Mar;41 Suppl 1:22-7
  Federal Legal Preparedness Tools for Facilitating Medical Countermeasure Use during Public Health Emergencies.
• JAMA Pediatr 2013 Mar 1;167(3):243-9
  Migraine therapeutics in adolescents: a systematic analysis and historic perspectives of triptan trials in adolescents.
• Clin Pharmacol Ther 2013 Apr 3 [Epub ahead of print]
  Regulatory and Scientific Issues Regarding Use of Foreign Data in Support of New Drug Applications in the U.S.: An FDA Perspective.
• Pediatrics 2013 Apr 8 [Epub ahead of print]
  FDA's Pediatric Device Consortia: National Program Fosters Pediatric Medical Device Development.
• Am Heart J 2013 Mar;165(3):344-353
  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.
• J Virol 2013 Apr;87(7):3801-14
  Ebola virus exploits a monocyte differentiation program to promote its entry.
• Food Microbiol 2013 May;34(1):182-8
  Growth and survival of Salmonella in ground black pepper (Piper nigrum).
• Ann Intern Med 2013 Jan 1;158(1):65-6
  Expanded access to opioid overdose intervention: research, practice, and policy needs.
• J Natl Med Assoc 2012 Sep-Oct;104(9-10):430-5
  Racial/Ethnic composition of study participants in FDA-approved oncology new molecular entities, 2006-2008.
• Pediatr Blood Cancer 2013 Apr;60(4):531-7
  The impact of the written request process on drug development in childhood cancer.
• Ther Deliv 2012 Dec;3(12):1383-94
  Current perspectives on the US FDA regulatory framework for intelligent drug-delivery systems.
• J Manag Care Pharm 2012 Nov;18(9):713-8
  The U.S. Food and drug administration: drug information resource for formulary recommendations.
• Sci Transl Med 2012 Dec 5;4(163):163fs43
  Creating a Space for Innovative Device Development.
• Am Heart J 2012 Oct;164(4):481-92
  Pediatric cardiovascular safety: Challenges in drug and device development and clinical application.
• Pediatrics 2012 Dec;130(6):e1583-91
  The Globalization of Pediatric Clinical Trials.
• PLoS Med 2012 Oct;9(10):e1001327
  Strengthening medical product regulation in low- and middle-income countries.
• Viruses 2012 Sep;4(9):1619-50
  Potential Vaccines and Post-Exposure Treatments for Filovirus Infections
• Econ Educ Rev 2012 Oct;31(5):709-19
  Do course evaluations truly reflect student learning? Evidence from an objectively graded post-test
• J Diabetes Sci Technol 2012 Sep 1;6(5):1087-93
  The Relationships between Common Measures of Glucose Meter Performance.
• J Diabetes Sci Technol 2012 Sep 1;6(5):1053-9
  Pediatric use of insulin pump technology: a retrospective study of adverse events in children ages 1-12 years.
• Paediatr Perinat Epidemiol 2012 Nov;26(6):578-88
  Trends in the Use of Antiepileptic Drugs among Pregnant Women in the US, 2001-2007: A Medication Exposure in Pregnancy Risk Evaluation Program Study.
• Med Care 2012 Nov;50(11):987-92
  Atomoxetine Use During a Period of FDA Actions.
• Clin Pharmacol Ther 2012 Oct;92(4):486-93
  Advancing the Science of Medicines Regulation: The Role of the 21st-Century Medicines Regulator.
• Microb Biotechnol 2012 Sep;5(5):588-93
  Meeting the challenges of medical countermeasure development.
• Food Drug Law J 2012;67(2):123-9
  Remarks at the Annual Conference of the Food and Drug Law Institute