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 2014_register executive 2014-03-01 article Notices D09002ee1c7fa5e87 D09002ee1c7fa5f22 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Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices." This draft guidance revises the final guidance titled "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on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" published in January 2009. The revised draft guidance provides guidance on FDA's current thinking on recommended practices for drug or medical device manufacturers and their representatives to follow when distributing to health care professionals or health care entities scientific or medical journal articles, scientific or medical reference texts, or clinical practice guidelines ((CPGs); all three collectively referred to as "scientific and medical publications") that discuss unapproved new uses for approved drugs or approved or cleared medical devices marketed in the United States. 79 FR 11793 https://www.govinfo.gov/app/details/FR-2014-03-03/2014-04560 2014-04560 fr03mr14-84 4160-01-P Docket No. FDA-2008-D-0053 https://www.govinfo.gov/app/details/FR-2014-03-03/2014-04560 https://www.govinfo.gov/content/pkg/FR-2014-03-03/html/2014-04560.htm https://www.govinfo.gov/content/pkg/FR-2014-03-03/pdf/2014-04560.pdf 4 p. 11793 11796 79 FR 11793 Revised Draft Guidance for Industry on Distributing Scientific and Medical Publications on Unapproved New Uses-Recommended Practices; Availability; Federal Register Vol. 79, Issue NOTICE 2014-04560 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2008-D-0053 4160-01-P 2014-04560 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices." This draft guidance revises the final guidance titled "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" published in January 2009. The revised draft guidance provides guidance on FDA's current thinking on recommended practices for drug or medical device manufacturers and their representatives to follow when distributing to health care professionals or health care entities scientific or medical journal articles, scientific or medical reference texts, or clinical practice guidelines ((CPGs); all three collectively referred to as "scientific and medical publications") that discuss unapproved new uses for approved drugs or approved or cleared medical devices marketed in the United States.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 2, 2014. Submit either electronic or written comments on the proposed collection of information by May 2, 2014. Regarding prescription drugs: Bryant Godfrey, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 51, Rm. 3258, Silver Spring, MD 20993-0002, 301- 796-1200. Draft Guidance for Industry and Staff: Distributing Scientific and Medical Publications on Unapproved New Uses Recommended Practices , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm http://www.regulations.gov Vol. 79, no. 41 Office of the Federal Register, National Archives and Records Administration 2014-03-03 continuing daily deposited born digital 360 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-03-03 P0b002ee18785b95e 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr03mr14 https://www.govinfo.gov/app/details/FR-2014-03-03 https://www.govinfo.gov/content/pkg/FR-2014-03-03/pdf/FR-2014-03-03.pdf https://www.govinfo.gov/content/pkg/FR-2014-03-03/xml/FR-2014-03-03.xml fdlp 11679 12029 DGPO 2014-03-01 2024-06-03 FR-2014-03-03 machine generated eng FR FR-2014-03-03 79 41