PhRMA Issues with FDA Medical Queries

Commenting on FDA’s plans for premarket reviews of safety data and safety signal detection, Pharmaceutical Research and Manufacturers of America (PhRMA) says that while FDA has identified a need for improvement in Medical Dictionary for Regulated Activities (MedDRA) standardized medical queries (SMQ), sponsors conduct clinical trials and execute submission strategies globally.

“A new region-specific set of medical queries outside of the MedDRA SMQ construct introduces variability and potential confusion in how sponsors and regulators evaluate the premarket safety of new therapies,” the association says. “PhRMA urges FDA to work with other global regulators through the International Council on Harmonization … and other organizations … to facilitate harmonization of the approach to premarket safety analytics.”

The submission also includes specific comments.