Gerald J. Dal Pan
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View article: A plasmode simulation-based bias analysis for residual confounding by unmeasured variables leveraging information-rich subsets
A plasmode simulation-based bias analysis for residual confounding by unmeasured variables leveraging information-rich subsets Open
Background Quantitative bias analyses often rely on unrealistic assumptions and do not fully reflect the complexities of healthcare data. Methods We describe a ‘plasmode’ simulation-based bias analysis for residual confounding from unmeasu…
View article: State‐of‐the‐Art Fabrication of Microneedle Patches: A Mini‐Review on Emerging Techniques
State‐of‐the‐Art Fabrication of Microneedle Patches: A Mini‐Review on Emerging Techniques Open
Microneedle (MN) patches are an emerging platform in transdermal drug delivery, offering a minimally invasive, pain‐free alternative to conventional administration routes. Their performance, biocompatibility, and clinical potential are fun…
View article: Trends in US Pediatric Unintentional Nonprescription Cold and Cough, Analgesic and Antipyretic Drug Exposure Cases amid the COVID-19 Pandemic
Trends in US Pediatric Unintentional Nonprescription Cold and Cough, Analgesic and Antipyretic Drug Exposure Cases amid the COVID-19 Pandemic Open
Background The coronavirus disease 2019 (COVID-19) pandemic dramatically impacted healthcare systems. Objective We assessed monthly unintentional pediatric (< 18 years) exposure case rate trends involving selected nonprescription cold and …
View article: <scp>FDA</scp> Adverse Event Reporting System (<scp>FAERS</scp>) Essentials: A Guide to Understanding, Applying, and Interpreting Adverse Event Data Reported to <scp>FAERS</scp>
<span>FDA</span> Adverse Event Reporting System (<span>FAERS</span>) Essentials: A Guide to Understanding, Applying, and Interpreting Adverse Event Data Reported to <span>FAERS</span> Open
The US Food and Drug Administration (FDA) performs safety assessments throughout the life cycle of a drug. Postmarketing safety surveillance promotes the identification of adverse events not known at the time of approval. Adverse event rep…
View article: Physician Experiences With and Perspectives on Clozapine Prescribing
Physician Experiences With and Perspectives on Clozapine Prescribing Open
Importance Clozapine is an effective medication for treatment-resistant schizophrenia but can cause agranulocytosis. Since its approval, patients taking clozapine have been required to undergo regular blood testing to screen for neutropeni…
View article: Enhancing Postmarketing Surveillance of Medical Products With Large Language Models
Enhancing Postmarketing Surveillance of Medical Products With Large Language Models Open
Importance The Sentinel System is a key component of the US Food and Drug Administration (FDA) postmarketing safety surveillance commitment and uses clinical health care data to conduct analyses to inform drug labeling and safety communica…
View article: Removing the FDA’s Boxed Hepatotoxicity Warning and Liver Function Testing Requirement for Ambrisentan
Removing the FDA’s Boxed Hepatotoxicity Warning and Liver Function Testing Requirement for Ambrisentan Open
Importance Endothelin receptor antagonists are first-line therapy for pulmonary arterial hypertension (PAH). The first 2 agents approved in the class, bosentan and ambrisentan, initially carried boxed warnings for hepatotoxicity and requir…
View article: Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study
Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study Open
Observed variations in consumer AE reporting may be related to sociodemographic factors and healthcare access. Because these factors may also correspond to AE susceptibility, voluntary AE reporting systems may be suboptimal for capturing e…
View article: Process guide for inferential studies using healthcare data from routine clinical practice to evaluate causal effects of drugs (PRINCIPLED): considerations from the FDA Sentinel Innovation Center
Process guide for inferential studies using healthcare data from routine clinical practice to evaluate causal effects of drugs (PRINCIPLED): considerations from the FDA Sentinel Innovation Center Open
This report proposes a stepwise process covering the range of considerations to systematically consider key choices for study design and data analysis for non-interventional studies with the central objective of fostering generation of rel…
View article: Trends in Incident Prescriptions for Behavioral Health Medications in the US, 2018-2022
Trends in Incident Prescriptions for Behavioral Health Medications in the US, 2018-2022 Open
Importance The COVID-19 pandemic reportedly increased behavioral health needs and impacted treatment access. Objective To assess changes in incident prescriptions dispensed for medications commonly used to treat depression, anxiety, attent…
View article: When can real‐world data generate real‐world evidence?
When can real‐world data generate real‐world evidence? Open
The terms real-world data (RWD) and real-world evidence (RWE) are often used inconsistently or interchangeably, including in submissions to the US Food and Drug Administration (FDA) involving RWE to evaluate the effectiveness of drugs and …
View article: The Food and Drug Administration’s (FDA’s) Drug Safety Surveillance During the COVID-19 Pandemic
The Food and Drug Administration’s (FDA’s) Drug Safety Surveillance During the COVID-19 Pandemic Open
View article: “Artificial Intelligence” for Pharmacovigilance: Ready for Prime Time?
“Artificial Intelligence” for Pharmacovigilance: Ready for Prime Time? Open
View article: Systemic Corticosteroid Use for COVID-19 in US Outpatient Settings From April 2020 to August 2021
Systemic Corticosteroid Use for COVID-19 in US Outpatient Settings From April 2020 to August 2021 Open
This study uses 2 large US health care claims databases (Medicare fee-for-service and the US Food and Drug Administration’s Sentinel System) to examine systemic corticosteroid use among nonhospitalized patients with COVID-19.
View article: Clinical Predictors of Lung Transplant Outcomes in Patients with Scleroderma Compared with Pulmonary Fibrosis
Clinical Predictors of Lung Transplant Outcomes in Patients with Scleroderma Compared with Pulmonary Fibrosis Open
View article: The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes
The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes Open
We characterized the size of the premarket safety population for 278 small‐molecule new molecular entities (NMEs) and 61 new therapeutic biologics (NTBs) approved by the US Food and Drug Administration (FDA) between October 1, 2002, and De…
View article: A <scp>COVID</scp>‐19‐ready public health surveillance system: The Food and Drug Administration's Sentinel System
A <span>COVID</span>‐19‐ready public health surveillance system: The Food and Drug Administration's Sentinel System Open
The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post‐market medical product safety. Over more than a decade, Se…
View article: Postmarketing Safety‐Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002–2014: Similarities and Differences With New Molecular Entities
Postmarketing Safety‐Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002–2014: Similarities and Differences With New Molecular Entities Open
We examined the relationship of regulatory and review characteristics to postmarketing safety‐related regulatory actions for 61 new therapeutic biologics (NTBs) approved between October 1, 2002 and December 31, 2014. We also compared NTBs …
View article: Changes in emergency department visits for zolpidem‐attributed adverse drug reactions after FDA Drug Safety Communications
Changes in emergency department visits for zolpidem‐attributed adverse drug reactions after FDA Drug Safety Communications Open
Purpose To identify possible changes in the U.S. emergency department (ED) visits from zolpidem‐attributed adverse drug reactions (ADRs) after 2013 Food and Drug Administration (FDA) Drug Safety Communications (DSCs), which notified the pu…
View article: The Role of Pharmacoepidemiology in Regulatory Agencies
The Role of Pharmacoepidemiology in Regulatory Agencies Open
Pharmacoepidemiology plays an important role in the regulation of medicines throughout the medicine's entire life cycle. Applications of pharmacoepidemiology include assessing the need for medicines, planning drug development programs, ana…
View article: Postmarketing Spontaneous Pharmacovigilance Reporting Systems
Postmarketing Spontaneous Pharmacovigilance Reporting Systems Open
Pharmacovigilance reporting systems provide the infrastructure that enables health professionals and consumers to alert health authorities and drug manufacturers when a suspected adverse drug reaction occurs. Postmarketing spontaneous repo…
View article: Discontinuation of Direct Oral Anticoagulants in Response to Attorney Advertisements: Data From the FDA Adverse Event Reporting System
Discontinuation of Direct Oral Anticoagulants in Response to Attorney Advertisements: Data From the FDA Adverse Event Reporting System Open
View article: Graphical Depiction of Longitudinal Study Designs in Health Care Databases
Graphical Depiction of Longitudinal Study Designs in Health Care Databases Open
Pharmacoepidemiologic and pharmacoeconomic analysis of health care databases has become a vital source of evidence to support health care decision making and efficient management of health care organizations. However, decision makers often…
View article: Assessing Drug Safety in Children — The Role of Real-World Data
Assessing Drug Safety in Children — The Role of Real-World Data Open
There are substantial gaps in evidence regarding the safety of many drugs in children. Increasingly, studies assessing drug safety can incorporate data obtained in the course of clinical care to generate real-world evidence and help fill t…
View article: New Opioid Analgesic Approvals and Outpatient Utilization of Opioid Analgesics in the United States, 1997 through 2015
New Opioid Analgesic Approvals and Outpatient Utilization of Opioid Analgesics in the United States, 1997 through 2015 Open
Background The opioid epidemic, driven in part by increased prescribing, is a public health emergency. This study examines dispensed prescription patterns and approvals of new opioid analgesic products to investigate whether the introducti…
View article: An Evaluation of “Drug Ineffective” Postmarketing Reports in Drug Safety Surveillance
An Evaluation of “Drug Ineffective” Postmarketing Reports in Drug Safety Surveillance Open
View article: Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis
Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis Open
Social media offers challenges and opportunities for dissemination of the DSC messages. The FDA could consider strategies for more actively disseminating DSC safety information through social media platforms, particularly when announcement…
View article: Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals
Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals Open
View article: The US Food and Drug Administration, neurologists, and drug development and regulation
The US Food and Drug Administration, neurologists, and drug development and regulation Open
The US Food and Drug Administration (FDA) plays a vital role in the regulation of human drugs and therapeutic biologics. Most physicians, while aware of the broad reach of the FDA, are unaware of what the agency actually does and how it do…
View article: Erratum to: Methodological Approaches to Evaluate the Impact of FDA Drug Safety Communications
Erratum to: Methodological Approaches to Evaluate the Impact of FDA Drug Safety Communications Open