GAO urges expansion of FDA’s limit on conditional approval for animal drugs

The U.S. Government Accountability Office (GAO) has recommended that Congress consider expanding the five-year limit on conditional approval of animal drugs by the U.S. Food and Drug Administration (FDA).

GAO also recommends FDA incorporate a benefit-risk assessment into its animal drug evaluations and that the FDA commissioner should develop guidance for industry on its use of benefit-risk assessments in its regulatory decisions for animal drugs.