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| 37855046 | When can real-world data generate real-world evidence? | Pharmacoepidemiol Drug Saf | 2024 |
| 36460854 | The Food and Drug Administration's (FDA's) Drug Safety Surveillance During the COVID-19 Pandemic. | Drug Saf | 2023 |
| 37391385 | Six Years of the US Food and Drug Administration's Postmarket Active Risk Identification and Analysis System in the Sentinel Initiative: Implications for Real World Evidence Generation. | Clin Pharmacol Ther | 2023 |
| 37021630 | Assessment of the Impact of Mandated Postmarketing Pediatric-Focused Safety Reviews on Safety-Related Regulatory Actions 2013-2019. | Clin Pharmacol Ther | 2023 |
| 34347101 | Patient-Reported Opioid Analgesic Use After Discharge from Surgical Procedures: A Systematic Review. | Pain Med | 2022 |
| 35579808 | "Artificial Intelligence" for Pharmacovigilance: Ready for Prime Time? | Drug Saf | 2022 |
| 35394487 | Systemic Corticosteroid Use for COVID-19 in US Outpatient Settings From April 2020 to August 2021. | JAMA | 2022 |
| 36094070 | The US Food and Drug Administration Sentinel System: a national resource for a learning health system. | J Am Med Inform Assoc | 2022 |
| 35113347 | Sources of Evidence Triggering and Supporting Safety-Related Labeling Changes: A 10-Year Longitudinal Assessment of 22 New Molecular Entities Approved in 2008 by the US Food and Drug Administration. | Drug Saf | 2022 |
| 34699061 | The Use of Real-World Data to Assess the Impact of Safety-Related Regulatory Interventions. | Clin Pharmacol Ther | 2022 |
| 33021566 | Patterns of opioid analgesic use in the U.S., 2009 to 2018. | Pain | 2021 |
| 33904111 | A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs. | Drug Saf | 2021 |
| 34931012 | Broadening the reach of the FDA Sentinel system: A roadmap for integrating electronic health record data in a causal analysis framework. | NPJ Digit Med | 2021 |
| 34382718 | Trend changes of national zolpidem users and exposure cases after FDA drug safety communications. | Pharmacoepidemiol Drug Saf | 2021 |
| 34057195 | The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes. | Clin Pharmacol Ther | 2021 |
| 32557564 | Postmarketing Safety-Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002-2014: Similarities and Differences With New Molecular Entities. | Clin Pharmacol Ther | 2020 |
| 31981082 | An Evaluation of Postmarketing Reports with an Outcome of Death in the US FDA Adverse Event Reporting System. | Drug Saf | 2020 |
| 31912439 | Towards Automating Adverse Event Review: A Prediction Model for Case Report Utility. | Drug Saf | 2020 |
| 33077615 | Leveraging the Capabilities of the FDA's Sentinel System To Improve Kidney Care. | J Am Soc Nephrol | 2020 |
| 32940401 | Randomized, observational, interventional, and real-world-What's in a name? | Pharmacoepidemiol Drug Saf | 2020 |
| 32790031 | FDA postmarketing safety labeling changes: What have we learned since 2010 about impacts on prescribing rates, drug utilization, and treatment outcomes. | Pharmacoepidemiol Drug Saf | 2020 |
| 32483401 | Changes in emergency department visits for zolpidem-attributed adverse drug reactions after FDA Drug Safety Communications. | Pharmacoepidemiol Drug Saf | 2020 |
| 30569267 | Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance. | Drug Saf | 2019 |
| 31302895 | Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem. | Drug Saf | 2019 |
| 31560634 | Patients' Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey. | J Law Med Ethics | 2019 |
| 31479525 | Impact of a New Consumer Form on the Quantity and Quality of Adverse Event Reports Submitted to the United States Food and Drug Administration. | Pharmacotherapy | 2019 |
| 31098918 | The Impact of Litigation-Associated Reports on Signal Identification in the US FDA's Adverse Event Reporting System. | Drug Saf | 2019 |
| 31034034 | Gauging the Effectiveness of Medicines Safety Communications From Global Regulatory Agencies. | JAMA Intern Med | 2019 |
| 30856654 | Graphical Depiction of Longitudinal Study Designs in Health Care Databases. | Ann Intern Med | 2019 |
| 31055957 | Discontinuation of Direct Oral Anticoagulants in Response to Attorney Advertisements: Data From the FDA Adverse Event Reporting System. | Ann Pharmacother | 2019 |
| 30958565 | Real-World Data, Advanced Analytics, and the Evolution of Postmarket Drug Safety Surveillance. | Clin Pharmacol Ther | 2019 |
| 29266187 | Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014. | Clin Pharmacol Ther | 2018 |
| 29874532 | Assessing Drug Safety in Children - The Role of Real-World Data. | N Engl J Med | 2018 |
| 29476420 | An Evaluation of "Drug Ineffective" Postmarketing Reports in Drug Safety Surveillance. | Drugs Real World Outcomes | 2018 |
| 29557812 | New Opioid Analgesic Approvals and Outpatient Utilization of Opioid Analgesics in the United States, 1997 through 2015. | Anesthesiology | 2018 |
| 29305342 | Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis. | JMIR Public Health Surveill | 2018 |
| 28000295 | Drug availability adjustments in population-based studies of prescription opioid abuse. | Pharmacoepidemiol Drug Saf | 2017 |
| 28339323 | Media Coverage of FDA Drug Safety Communications about Zolpidem: A Quantitative and Qualitative Analysis. | J Health Commun | 2017 |
| 28247279 | Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study. | Drug Saf | 2017 |
| 28449404 | Changes in prescribing and healthcare resource utilization after FDA Drug Safety Communications involving zolpidem-containing medications. | Pharmacoepidemiol Drug Saf | 2017 |
| 28342075 | Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals. | Drug Saf | 2017 |
| 26853718 | Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions. | Clin Pharmacol Ther | 2016 |
| 26667601 | The FDA's sentinel initiative--A comprehensive approach to medical product surveillance. | Clin Pharmacol Ther | 2016 |
| 27959688 | Real-World Evidence - What Is It and What Can It Tell Us? | N Engl J Med | 2016 |
| 25539878 | The US Food and Drug Administration-European Medicines Agency collaboration in pharmacovigilance: common objectives and common challenges. | Drug Saf | 2015 |
| 29443198 | The US Food and Drug Administration, neurologists, and drug development and regulation. | Neurol Clin Pract | 2015 |
| 26201399 | Erratum to: Methodological Approaches to Evaluate the Impact of FDA Drug Safety Communications. | Drug Saf | 2015 |
| 25968811 | Methodological approaches to evaluate the impact of FDA drug safety communications. | Drug Saf | 2015 |
| 25670505 | Patterns in spontaneous adverse event reporting among branded and generic antiepileptic drugs. | Clin Pharmacol Ther | 2015 |
| 25808393 | Patient understanding of drug risks: an evaluation of medication guide assessments. | Pharmacoepidemiol Drug Saf | 2015 |