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Home
  • About
    • Board of Directors
    • Our Staff
    • Annual Reports
    • Policies
    • Careers
  • Programs
    • Research
      • IMEDS
      • Post Market Research
      • RAISE
      • Real World Data
    • Antimicrobial Use Data in Food Animals
    • Expanded Access Navigator
    • Food & Nutrition
    • Substance Use Disorders
    • FDA Operational Evaluation
    • FDA Patient Listening Sessions
    • COVID-19 Hub
    • Fellowship
  • News and Events
    • 2023 Annual Public Meeting
    • Innovations in Regulatory Science Awards
    • News
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Publications

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INDEPENDENT PUBLICATIONS
FOUNDATION REPORTS
JOURNAL ARTICLES
ARCHIVES

 

Independent Publications

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Operational Evaluation of Human Foods Program

Operational Evaluation of the FDA's Human Foods Program

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Operational Evaluation Tobacco Cover

Operational Evaluation of Certain Components of FDA's Tobacco Program

Foundation Reports

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Naloxone Report cover

Naloxone Economic View: Summary Report

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Snapshot 2022 Cover

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

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Covid-19 RWE Primer Cover

COVID-19 Real-World Evidence Primer

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AMU Summary Report Cover

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 Cover

COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics

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Clinical Trial Design Stimulant Use Disorder Research Cover

A Practical Research Agenda for Treatment Development for Stimulant Use Disorder

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FTS Clinician Roundtable Cover

Harm Reduction: Clinical Perspectives Summary Report

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FTS Community Roundtable Cover

Harm Reduction: Community Perspectives Summary Report

 

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Payor Perspective Cover

Payor Perspectives on Substance Use Disorder Treatment

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Individual Clinician Pharmacist Perspectives Medication Opioid Use Disorder Cover

Substance Use Disorder Treatment Journeys Executive Summary

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RDBA Cover

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

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Leveraging Real World Treatment Experience EA Protocols Cover

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

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© Reagan-Udall Foundation for the FDA
© Reagan-Udall Foundation for the FDA