federal_register: 2017-26978

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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
2017-26978 Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop; Request for Comments Notice The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled "Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data." The purpose of the public workshop is to convene a discussion on how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the Agency. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act (Cures Act). FDA plans to publish a background document approximately 2 weeks before the workshop date. 2017-12-14 2017 12 https://www.federalregister.gov/documents/2017/12/14/2017-26978/patient-focused-drug-development-developing-and-submitting-proposed-draft-guidance-relating-to https://www.govinfo.gov/content/pkg/FR-2017-12-14/pdf/2017-26978.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled "Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data." The purpose of the public...  

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