CDRH COVID-19-Related Workload Impacts Q-Submission Reviews
In recent weeks, NAMSA has become aware of instances in which the U.S. Food and Drug Administration (FDA) CDRH Office has closed Q-Submissions without review, citing resource constraints stemming from the COVID-19 Pandemic. With the FDA’s commitment to protecting public health, the agency has allocated resources to focus on COVID-19-related activities, working alongside other federal, state and local agencies and officials to address the pandemic.