federal_register: E9-452

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E9-452 Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices." The guidance provides drug, biologics, and device manufacturers with the agency's views on the distribution of medical journal articles and scientific or medical reference publications that discuss unapproved new uses for FDA- approved drugs or biologics or FDA-approved or cleared medical devices to healthcare professionals and healthcare entities. 2009-01-13 2009 1 https://www.federalregister.gov/documents/2009/01/13/E9-452/guidance-for-industry-on-good-reprint-practices-for-the-distribution-of-medical-journal-articles-and https://www.govinfo.gov/content/pkg/FR-2009-01-13/pdf/E9-452.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses...

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