An Analysis of Pharmaceutical Quality Deficiencies Responsible for Clinical Holds in Investigational New Drug Applications

Authors:: Poster Author(s)

Chatterjee, Rohan, FDA/CDER (Student); Yang, Jack, FDA/CDER (Student); Wu, Larisa, FDA/CDER (Mentor); Wesdyk, Russell, FDA/CDER (Mentor)

Center:: Contributing Office

Center for Drug Evaluation and Research

Abstract

Poster Abstract

The purpose of this study is to conduct a systematic data search and analysis of pharmaceutical quality related safety issues in quality reviews of Investigational New Drug Applications (INDs) to understand the chemistry, manufacturing and controls (CMC) reasons behind clinical holds in INDs. We have looked at over 1000 Commercial and Research IND applications received at CDER from June 1st, 2016 to June 1st, 2021 and identified those placed on clinical holds due to quality related safety issues. Furthermore, for the 147 commercial INDs and 211 research INDs placed on clinical holds during this time period, we identified and quantified the quality related safety issues , and categorized and tagged them in a way that allowed us to analyze the data meaningfully. Using this tagged data, we classified CMC issues to produce descriptive statistics and data visualizations on the most common reasons leading to clinical holds. The knowledge generated by understanding the results of our study will help inform the development of effective regulatory assessment practices in the Office of New Drug Product (ONDP)/Office of Pharmaceutical Quality (OPQ), including a Knowledge-aided Assessment and Structured Application (KASA) system for INDs.