Center for Drug Evaluation and Research

Naloxone Distribution in the United States, 2018-2023.

. 2026;116(10):1613-1616. https://doi.org/10.2105/AJPH.2026.308541).

Physician Understanding and Perceptions of Risk Communication Related to Drugs Covered by Risk Evaluation and Mitigation Strategy Programs

ABSTRACT Purpose To help ensure that a drug's benefits outweigh its risks, the US Food and Drug Administration may require a Risk Evaluation and Mitigation Strategy (REMS) program with requirements such as laboratory tests or special education. Since physicians are often responsi...

Toward actionable biomarkers in psychiatry: a collaborative roadmap for precision clinical trials. An ACNP position paper

Abstract Psychiatric drug development remains constrained by diagnostic heterogeneity, insufficient and inconsistent drug response, high placebo response rates, and the absence of validated biomarkers that can reliably guide patient stratification, trial design, and regulatory de...

Injecting Pills in the Late Fentanyl Era: A Qualitative Investigation of the Procedures Used to Prepare and Inject Prescription Opioids

Background The current study offers updated information on how PWID prepare and inject prescription and illicit drugs. The main objective was to identify potential pathways and reservoirs of infection associated with the tools and techniques used to inject prescription opioids.Me...

Enhancing Evidence Generation by Linking Randomized Clinical Trials to Real‐World Data: The INVESTED‐Medicare Linkage Study

Real‐world evidence (RWE) derived from real‐world data (RWD) can complement randomized controlled trials (RCTs), yet the validity of RWD relative to RCT data remains insufficiently characterized. We obtained post hoc consent and linked individual participant data from the US‐base...

Analysis of Suffix Use for Biosimilar Product Identification in Postmarketing Adverse Event Reporting

Accurate identification of medicines used in adverse event reports is crucial for effective postmarketing safety surveillance. The US Food and Drug Administration's (FDA) four‐letter suffix naming convention was designed to facilitate accurate biological product identification, b...

Regulatory and scientific challenges in paediatric oncology

INTRODUCTION: Pediatric oncology poses distinct scientific, ethical, regulatory, and commercial challenges compared to adult oncology. Although survival rates for certain childhood malignancies have improved significantly, progress in relapsed, refractory, and rare pediatric canc...

A Multistate Investigation of Serious Adverse Events, including Deaths, following Ceftriaxone Injections, September 2024–August 2025

BACKGROUND: Reports of ceftriaxone serious adverse events (SAEs), including deaths, from multiple jurisdictions during December 2024-January 2025 prompted a nationwide investigation to evaluate product safety, characterize SAEs, and assess for changes in baseline adverse event oc...

Tracking regulatory convergence in Asia-Pacific Economic Cooperation (APEC): progress and gaps in key performance indicators

Abstract Purpose To assess progress in regulatory convergence among APEC economies using updated Key Performance Indicators (KPI) and to identify opportunities for strengthening reliance and work sharing, while informing future Phase 2 KPI development. Our work describes the adop...

Discovery of TL10:A Soluble and Long-Acting MC4RAgonist with Tunable Lipidation for Sustained Pharmacological Activity

Abstract The development of long-acting MC4R peptide agonists remains challenging due to rapid clearance and structural sensitivity, where conventional permanent lipidation strategies often impair receptor engagement. Here, we report the discovery and characterization of TL10, a...

Implementing the Zero Suicide Framework in a Statewide Youth Behavioral Health System: A Qualitative Study

Background The health-care system is an important point of intervention for youth suicide, and the Zero Suicide framework offers a comprehensive, evidence-informed approach to suicide prevention within health-care systems. Researchers evaluated implementation of the Zero Suicide...

Adverse Reactions Identified after Approval of Novel Medicines: Analysis of 339 New Molecular Entities and Therapeutic Biologics

Postmarketing safety surveillance data identify safety issues not identified in preapproval clinical trials. We describe the frequency of new safety issues overall and by labeling section and the relationship of the most commonly added safety issues with the cumulative number of...

FDA Approval Summary: Retifanlimab for the treatment of adult patients with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal

Abstract On May 15, 2025, the Food and Drug Administration approved retifanlimab in combination with carboplatin and paclitaxel for treating unresectable or metastatic squamous cell carcinoma of the anal canal (SCAC), and as a single agent for second-line SCAC treatment. These ap...