New CDER Initiatives Will Gather Feedback on Quality Metrics

CDER launched two new efforts to gather feedback about the use of quality metrics in modernizing drug quality systems, calling for participants in a voluntary pilot program and encouraging meeting requests.

One of its efforts, the Quality Metrics Feedback Program, encourages new drug application holders to submit Type C formal meeting and pre-ANDA meeting requests, so companies can talk to the agency and share information about their quality metric programs and get the agency’s feedback.

The other initiative, the center’s Quality Metrics Pilot Program, is intended to gather information and feedback for the agency’s Quality Metrics Program (QMP). The pilot is limited to nine or fewer firms that meet certain criteria. To be eligible, firms must manufacture, compound or process a covered drug product or an API used in the manufacturing of a covered drug.