federal_register: 2011-27037

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-27037 Orphan Drug Regulations Proposed Rule The Food and Drug Administration (FDA) is proposing to amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued. 2011-10-19 2011 10 https://www.federalregister.gov/documents/2011/10/19/2011-27037/orphan-drug-regulations https://www.govinfo.gov/content/pkg/FR-2011-10-19/pdf/2011-27037.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that...

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