Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Draft Guidance for Industry; Availability; Extension of Comment Period

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The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of December 20, 2017. In the notice of availability, FDA requested comments on the draft guidance for industry entitled "Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases." The Agency is taking this action in response to public interest in the draft guidance and to allow interested persons additional time to submit comments.