Economic Studies of FDA Regulations I

Provide accurate and timely economic assessments of FDA regulatory actions. These analyses have high public visibility and, therefore, must withstand intense scientific and technical review and scrutiny by diverse audiences including the public, regulated entities, Government agencies such as the Department of Health and Human Services and the Office of Management and Budget, the U.S. Congress, professional economists, and the scientific and medical community. The need of the Economics Staff for support by a contractor arises from the variety and complexity of the work, the need to have access to specialized resources to rapidly gather data to meet tight deadlines, and the need for research involving direct contact with regulated entities.