FDA sanctions more time to the drugmakers to join Quality Metrics Feedback Program


The submission period for the Quality Metrics Feedback Program, which was instigated by the U.S. Food and Drug Administration (FDA) in June 2018, has been reopened with another 120 days extension. The window was last closed in June this year. The other program- Quality Metrics Site Visit Program has also been extended with the submission period for the site visit program by 120 days.

The feedback program intends to solicit Type C Formal Meetings and abbreviated new drug application (ANDA) from the New Drug Application (NDA) holders to submit pre-ANDA meeting requests to discuss quality metrics with the agency.