FOUNDATION REPORTS        INDEPENDENT PUBLICATIONS         JOURNAL ARTICLES        ARCHIVES

Foundation Reports

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Industry Roundtable Series on the FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods Top-Line Learnings Summary
Real-world Data to Assess Long-term Impact of FDA Food-related Regulations and Policies

Real-world Data to Assess Long-Term Impact of FDA Food-related Regulations and Policies
Biomarkers Workshop Summary

Qualifying Biomarkers to Support Rare Disease Regulatory Pathways: Proceedings Summary
Data Feed Report

Improving Access to Publicly Available FDA Information
Advancing Psychedelic Clinical Study Design

Advancing Psychedelic Clinical Study Design
In Silico Technologes

In Silico Technologies
Xylazine Report

Mitigating Risks from Human Xylazine Exposure
In Silico Alternative Methods Cluster Summary Report

In Silico Alternative Methods Cluster Summary Report
GSP Cover 2.2.24

Good Simulation Practices/Computational Modeling & Simulation Cluster Summary Report
Evidence Generation

Enhancing Post-Market Evidence Generation for Medical Products
Strategies Report

Strategies for Improving Public Understanding of FDA-Regulated Products
Bupe Cover

Considerations for Buprenorphine Initiation and Maintenance Care
Establishing a Draft Framework for a Public-Private Partnership to Support the Tracking of Antimicrobial Use in Food-Producing Animals

Establishing a Draft Framework for a Public-Private Partnership to Support the Tracking of Antimicrobial Use in Food-Producing Animals
Fatal Overdose

Understanding Fatal Overdose
Naloxone Report cover

Naloxone Economic View: Summary Report
Snapshot 2022 Cover

Snapshot 2022: A Changing Environment for FDA-regulated Consumer Products
Covid-19 RWE Primer Cover

COVID-19 Real-World Evidence Primer
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
Covid-19 Lessons Learned Cover

COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics
Clinical Trial Design Stimulant Use Disorder Research Cover

A Practical Research Agenda for Treatment Development for Stimulant Use Disorder
FTS Clinician Roundtable Cover

Harm Reduction: Clinical Perspectives Summary Report
FTS Community Roundtable Cover

Harm Reduction: Community Perspectives Summary Report
Payor Perspective Cover

Payor Perspectives on Substance Use Disorder Treatment
Individual Clinician Pharmacist Perspectives Medication Opioid Use Disorder Cover

Substance Use Disorder Treatment Journeys Executive Summary
RDBA Cover

Supporting Healthier Eating in the New Normal: Ultimate Retail Dietician Toolkit
Leveraging Real World Treatment Experience EA Protocols Cover

Leveraging Real-World Treatment Experience From Expanded Access Protocols

Independent Publications

Operational Evaluation of Human Foods Program

Operational Evaluation of the FDA's Human Foods Program
Operational Evaluation Tobacco Cover

Operational Evaluation of Certain Components of FDA's Tobacco Program

Journal Articles

Advancing Health Equity: Efforts to Expand Education on Skin Lightening Products Public Health Reports

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