United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2009_register executive 2010-09-23 article Notices D09002ee1c8077856 D09002ee1c80778da United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 74 FR 1694 https://www.govinfo.gov/app/details/FR-2009-01-13/E9-452 E9-452 fr13ja09-59 4160-01-S Docket No. FDA-2008-D-0053 https://www.govinfo.gov/app/details/FR-2009-01-13/E9-452 https://www.govinfo.gov/content/pkg/FR-2009-01-13/html/E9-452.htm https://www.govinfo.gov/content/pkg/FR-2009-01-13/pdf/E9-452.pdf 2 p. 1694 1695 74 FR 1694 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; Federal Register Vol. 74, Issue NOTICE E9-452 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2008-D-0053 4160-01-S E9-452 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.

Submit written or electronic comments on agency guidances at any time. Jarilyn Dupont, Office of Policy, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 4305, Silver Spring, MD, 20993-0002, 301- 796-4830. Guidance for Industry: 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, http://www.fda.gov/oc/op/goodreprint.html http://www.regulations.gov Vol. 74, no. 8 Office of the Federal Register, National Archives and Records Administration 2009-01-13 continuing daily deposited born digital 293 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2009-01-13 P0b002ee1809a69a8 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13ja09 https://www.govinfo.gov/app/details/FR-2009-01-13 https://www.govinfo.gov/content/pkg/FR-2009-01-13/pdf/FR-2009-01-13.pdf https://www.govinfo.gov/content/pkg/FR-2009-01-13/xml/FR-2009-01-13.xml fdlp 1583 1869 DGPO 2010-09-23 2024-06-05 FR-2009-01-13 machine generated eng FR FR-2009-01-13 74 8