Pharmaceutical companies are asking the US Food and Drug Administration (FDA) for more adverse events reporting standardization by harmonizing with standards organizations as well as further clarity around key terms. Their comments are in response to a recent workshop on the topic and documents released by the agency.
Lack of standardization of safety data analysis and visualization, as well as inconsistencies in how adverse events are defined, categorized, analyzed, and presented in marketing applications, has led to concerns about whether safety data is being accurately presented, according to FDA. That concern prompted the Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) to develop two documents on the topic.
The first document, titled FDA Medical Queries (FMQ), proposes standardizing preferred terms of adverse events using the Medical Dictionary for Regulatory Activities (MedDRA). The second document, Standard Safety Tables and Figures Integrated Guide, proposes standardized methods to visualize clinical trial safety data in tables and figures…
