FDA Seeks Industry Volunteers for 2018 Quality Metrics Site Visit Program

The FDA invited drugmakers to allow non-regulatory site visits of their facilities by CDER and CBER staff as part of its Quality Metrics Program.

The voluntary site visit program “is designed to offer experiential and firsthand learning opportunities to CDER and CBER staff… and to provide stakeholders with an opportunity to explain the advantages and challenges” involved in running a QMP, the agency said.

An estimated five to ten agency representatives involved in QMP development are expected to participate in each visit, which typically take place over one or two days. The firm may present outlines of the development and management of their QMP, expediting the learning process for FDA staff and allowing firms the opportunity to present the technologies used in their program.