Challenges
FDA Medical Queries (FMQs) are standardized groupings of related terms representing a medical concept, which are designed to improve safety signal detection, as well as to increase efficiency and consistency of the process
Development of Standard Safety Tables and Figures can streamline the data used for generating analyses, foster consistency in the visualizations utilized, and aid FDA clinical review staff in the interpretation of analyses
Clinical judgment is important, given exploratory nature of these analyses
Complying with Requirements for Aggregate IND Safety Reports
The important thing is to have a thoughtful process; a system in place to look for clinically important imbalances, applying the best clinical and quantitative judgment, while maintaining trial integrity.
–Jacqueline Corrigan-Curay (Principal Deputy Center Director in FDA’s Center for Drug Evaluation and Research)
Scientific evaluation of accumulating program-level safety information throughout product development, leveraging scientific expertise and medical judgment of multidisciplinary teams
- A multidisciplinary approach
- Assessments customized for the specific product
- Quantitative frameworks for measuring evidence of association
- Decisions that incorporate medical judgment
Over 20 Years of Aggregate Safety Expertise
We are helping our clients consistently and authoritatively communicate their safety story in scientific evaluations and public disclosures