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  1. Designating an Orphan Product: Drugs and Biological Products

Improving the Prevention, Diagnosis, and Treatment of Rare and Neglected Diseases; FDA Report to Congress

Report to Congress

Improving the Prevention, Diagnosis, and Treatment of Rare and Neglected Diseases

In Response to: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010, Public Law 111-80, Section 740

Department of Health and Human Services,
Food and Drug Administration
March 2011

INTRODUCTION

Section 740 of the fiscal year (FY) 2010 Appropriation Act (Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriation Act, 2010, Public Law 111-80), dated October 21, 2009, required the Commissioner, Food and Drug Administration (FDA), to establish two review groups within FDA to make recommendations to the FDA Commissioner on appropriate preclinical, trial design, and regulatory paradigms and optimal solutions to prevent, diagnosis, and treat (1) rare diseases and (2) neglected diseases of the developing world. Section 740 requires these groups to submit a report to Congress that describes their findings and recommendations.