Publications

Independent Publications

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Operational Evaluation of the FDA's Human Foods Program

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Operational Evaluation of Certain Components of FDA's Tobacco Program

Foundation Reports

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Naloxone Economic View: Summary Report

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Snapshot 2022: A Changing Environment for FDA-regulated Consumer Products

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COVID-19 Real-World Evidence Primer

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Exploring the Potential for A Public-Private Partnership to Support the Tracking and Monitoring of Antimicrobial Use in Food-Producing Animals

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COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics

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A Practical Research Agenda for Treatment Development for Stimulant Use Disorder

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Harm Reduction: Clinical Perspectives Summary Report

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Harm Reduction: Community Perspectives Summary Report

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Payor Perspectives on Substance Use Disorder Treatment

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Substance Use Disorder Treatment Journeys Executive Summary

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Supporting Healthier Eating in the New Normal: Ultimate Retail Dietician Toolkit

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Leveraging Real-World Treatment Experience From Expanded Access Protocols

Journal Articles

Considerations for defining medication exposure when analyzing real-world data Pharmacoepidemiology & Drug Safety

Generating evidence for racial and ethnic minorities during development of oncologic therapeutics Regulatory Focus

Real-World Performance of SARS-Cov-2 Serology Tests in the United States, 2020. PLoS ONE

Development and Evaluation of the Algorithm CErtaInty Tool (ACE-IT) to Assess Electronic Medical Record and Claims-based Algorithms’ Fit for Purpose for Safety Outcomes. Drug Safety

The US Food and Drug Administration Sentinel System: a national resource for a learning health system. Journal of the American Medical Informatics Association  

COVID-19 is associated with higher risk of venous thrombosis, but not arterial thrombosis, compared with influenza: Insights from a large US cohort. PLoS ONE

Sharing Health Data: The Why, the Will, and the Way Forward 
A Special Publication from the National Academy of Medicine, January 2022

Archives

2021

Journal Articles

The use of narrative electronic prescribing instructions in pharmacoepidemiology: A scoping review for the International Society for Pharmacoepidemiology Pharmacoepidemiology & Drug Safety

Post-COVID-19 Syndrome: Leveraging the Patient Perspective and Technological Innovations to Enable the Delineation of Effective Treatments. Drugs 

OSE's annual report details Sentinel efforts during COVID pandemic. Regulatory Focus, May 2021

Characteristics Associated with Time-to-Treatment Initiation for Chronic Hepatitis C with New Direct Acting Antivirals. Pharmacoepidemiology & Drug Safety

COVID-19 Vaccine Confidence Project  Journal of the American Pharmacists Association 

COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients. PLOS One

2020

Journal Articles

FDA Applauds Role of Clinical Trials in Fighting COVID-19. Association of Clinical Research Professionals. Association of Clinical Research Professionals 2020

Validity of an Automated Algorithm to Identify Cirrhosis Using Electronic Health Records in Patients with Primary Biliary Cholangitis. Clinical Epidemiology