FDA Resources

Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) resource allocation, workload, and review time for biologics, human drugs, medical devices, food additives, and animal drugs. GAO noted that: (1) the amount of resources needed for each application review varies by product type; (2) in general, review times are shorter for application reviews that require fewer resources; (3) resource allocation also varies by each review center's product mix at any given time; and (4) FDA has initiated a number of changes to increase the efficiency of its product review process, but their effectiveness are not yet known.