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 2017_register executive 2018-10-25 article Notices D09002ee1c7eeb3d7 D09002ee1c7eeb6a8 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 or Agency) is announcing the availability of a guidance for industry entitled "Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements." The guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for human prescription drugs, including prescription biological products, and for animal prescription drugs. This guidance finalizes the revised draft guidance issued on November 20, 2013 ("Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling"). FDA is also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). 82 FR 58421 https://www.govinfo.gov/app/details/FR-2017-12-12/2017-26725 2017-26725 fr12de17-45 4164-01-P Docket No. FDA-1999-D-4079 https://www.govinfo.gov/app/details/FR-2017-12-12/2017-26725 https://www.govinfo.gov/content/pkg/FR-2017-12-12/html/2017-26725.htm https://www.govinfo.gov/content/pkg/FR-2017-12-12/pdf/2017-26725.pdf 4 p. 58421 58424 82 FR 58421 Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements; Guidance for Industry; Availability; Federal Register Vol. 82, Issue NOTICE 2017-26725 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-1999-D-4079 4164-01-P 2017-26725 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements." The guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for human prescription drugs, including prescription biological products, and for animal prescription drugs. This guidance finalizes the revised draft guidance issued on November 20, 2013 ("Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling"). FDA is also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

The announcement of the guidance is published in the Federal Register on December 12, 2017. Regarding human prescription drugs: Sheila Ryan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3320, Silver Spring, MD 20993-0002, 301-796-1200. Regarding human prescription biological products: Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Regarding animal prescription drugs: Thomas Moskal, Center for Veterinary Medicine (HFV-216), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6251. Guidance: Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements , oira_submission@omb.eop.gov https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 82, no. 237 Office of the Federal Register, National Archives and Records Administration 2017-12-12 continuing daily deposited born digital 208 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2017-12-12 P0b002ee19d7bdc9f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr12de17 https://www.govinfo.gov/app/details/FR-2017-12-12 https://www.govinfo.gov/content/pkg/FR-2017-12-12/pdf/FR-2017-12-12.pdf https://www.govinfo.gov/content/pkg/FR-2017-12-12/xml/FR-2017-12-12.xml fdlp 58333 58532 DGPO 2018-10-25 2024-06-01 FR-2017-12-12 machine generated eng FR FR-2017-12-12 82 237