federal_register: 2018-00418

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2018-00418 Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Draft Guidance for Industry; Availability; Extension of Comment Period Notice The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice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 In the notice of availability, FDA requested comments on the draft guidance for industry entitled "Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases." The Agency is taking this action in response to public interest in the draft guidance and to allow interested persons additional time to submit comments. 2018-01-12 2018 1 https://www.federalregister.gov/documents/2018/01/12/2018-00418/clarification-of-orphan-designation-of-drugs-and-biologics-for-pediatric-subpopulations-of-common https://www.govinfo.gov/content/pkg/FR-2018-01-12/pdf/2018-00418.pdf Health and Human Services Department; Food and Drug Administration 221,199 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 In the notice of availability, FDA requested comments on the draft guidance for...  

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