federal_register: 2017-20521

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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
2017-20521 Devices Proposed for a New Use With an Approved, Marketed Drug; Public Hearing; Request for Comments Notice The Food and Drug Administration (FDA or the Agency) is announcing a public hearing on a potential approach for device sponsors who seek to obtain marketing authorization for their products that are labeled for a new use with an approved, marketed drug when the sponsor for the approved drug does not wish to pursue or collaborate on the new use. 2017-09-26 2017 9 https://www.federalregister.gov/documents/2017/09/26/2017-20521/devices-proposed-for-a-new-use-with-an-approved-marketed-drug-public-hearing-request-for-comments https://www.govinfo.gov/content/pkg/FR-2017-09-26/pdf/2017-20521.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is announcing a public hearing on a potential approach for device sponsors who seek to obtain marketing authorization for their products that are labeled for a new use with an approved, marketed drug...  

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