RECENT SPOTLIGHT ON CDER SCIENCE

CDER continues with its Spotlight on CDER Science series featuring the Center’s noteworthy scientific and research-oriented activities. The latest spotlight articles include:

New FDA Study Shines Light on Sunscreen Absorption.

In a study recently published in the Journal of the American Medical Association (JAMA), CDER scientists conducted a pilot study and learned that four active ingredients commonly found in sunscreen (avobenzone, oxybenzone, octocrylene, and ecamsule) were absorbed through the skin into the body.

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IN PRESS

Recent Publications by CDER Scientists

Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology

To better inform resource allocation and workload management for Abbreviated New Drug Application submissions a machine learning algorithm was employed to predict the first submission.  This model performed well in both internal and external validations and can serve as an effective planning tool for generic applications.

The potential role of the J-Tpeak interval in proarrhythmic cardiac safety: current state of the science from the American college of clinical pharmacology and the cardiac safety research consortium

Drug-induced arrhythmia can lead to many complications, including death. Identifying drugs early in development that may cause arrhythmia is key, and an informative cardiac biomarker that can recognize these drugs has been of recent interest.  The authors review the evidence supporting one potential ECG-based biomarker, the J-Tpeak interval, which is a focus of the Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative and may be useful to gain additional insight into drugs associated with arrhythmias.