Rare Diseases: Considerations for the Development of Drugs and Biological Products; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Rare Diseases: Considerations for the Development of Drugs and Biological Products." This guidance is intended to assist sponsors of drugs and biological products for treatment of rare diseases in conducting efficient and successful drug development programs through a discussion of selected issues commonly encountered in rare disease drug development. This guidance finalizes the draft guidance entitled "Rare Diseases: Common Issues in Drug Development" issued on February 1, 2019.