CDER HIGHLIGHTS

CDER HIGHLIGHTS

Research update from the Office of Biostatistics (OB)/Office of Translational Sciences (OTS) and Office of Surveillance and Epidemiology (OSE) Development of the software, geoMapr (Geographically-enriched Machine-aided analysis of Prescription Drug Utilization Data), for enriched analysis of drug utilization data In post-market safety surveillance, pharmacy dispensing data provide valuable insights to the Agency for the analysis of drug utilization. Our web-based software (geoMapr) provides tools to augment the nationally representative prescription drug dispensing data with other geographically referenced, publicly available, demographic, socioeconomic, or healthcare service data. geoMapr subsequently generates presentation-ready results of the surveillance data analyses, including user-interactive data tabulations, visualization, and machine learning for identifying factors highly associated with drug utilization. geoMapr has been used to analyze the prescribing trends for opioid antagonists such as naloxone and buprenorphine. Future enhancement to geoMapr include spatial modeling to explore factors associated with geographical variations in prescription drug dispensing.

Research update from the Office of Pharmaceutical Quality (OPQ) Identifying/Evaluating failure of insulin drug products under real world stress conditions:

Diabetic patients depend heavily on insulin drug products (DPs) to regulate their blood glucose. The Office of Biotechnology Products (OBP) in OPQ evaluates the quality of insulin DPs. OBP assessors and research labs have been working closely together as part of the OBP Insulin Working Group (IWG) to address potential quality issues related to insulin DPs. Unlike other biotechnology DPs, insulin DPs are predominantly self-administered and are available in both vial and pen presentations. OBP is looking at potential real-world storage and handling scenarios of insulin DPs by the patients beyond the standard in-use and supportive stability study conditions typically seen in a marketing  application. This collaborative approach aims to improve product manufacturing, testing and surveillance to help ensure the availability of high-quality drugs, and to identify decision-making tools and resources that will enable effective risk-based decisions through best practices, analytics and research findings. The outcomes of this collaboration are to both provide internal resources for regulatory staff and publish peer reviewed manuscripts to share with the broader scientific community.

Update from the Guidance, Policy and Communications Team, Office of Translational Sciences Immediate Office FDA Publishes Guidance Snapshots: Visual Communication Tool for Clinical Trial and Drug Development Guidance Documents