What is PQRI?

The Product Quality Research Institute (PQRI) is a collaborative process involving FDA’s Center for Drug Evaluation and Research (CDER), Industry, and Academia. The mission of PQRI is to conduct research to generate specific scientific information that should be submitted in a regulatory filing to CDER. PQRI has been in development since January of 1996, guided by a Steering Committee composed of representatives from its sponsoring organizations.

PQRI member organizations, representing industry, academia, and government, cover a wide array of scientific issues related to pharmaceutical products. Through its working groups and technical committees, PQRI tackles projects to ensure the quality, safety and performance of drug products. We invite you to learn more about our current projects, meetings, and publications.