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 2008_register executive 2010-09-23 article Notices D09002ee1c808ae96 D09002ee1c808af21 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 "Indexing Structured Product Labeling." This guidance explains that the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) will index structured product labeling (SPL) in the product labeling for human drug and biologic products. This guidance also makes recommendations to industry on how to submit input regarding the indexing information in the SPL. 73 FR 31492 https://www.govinfo.gov/app/details/FR-2008-06-02/E8-12158 E8-12158 fr02jn08-89 4160-01-S Docket No. FDA-2007-D-0364 https://www.govinfo.gov/app/details/FR-2008-06-02/E8-12158 https://www.govinfo.gov/content/pkg/FR-2008-06-02/html/E8-12158.htm https://www.govinfo.gov/content/pkg/FR-2008-06-02/pdf/E8-12158.pdf 2 p. 31492 31493 73 FR 31492 Guidance for Industry on Indexing Structured Product Labeling; Availability; Federal Register Vol. 73, Issue NOTICE E8-12158 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2007-D-0364 4160-01-S E8-12158 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Indexing Structured Product Labeling." This guidance explains that the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) will index structured product labeling (SPL) in the product labeling for human drug and biologic products. This guidance also makes recommendations to industry on how to submit input regarding the indexing information in the SPL.

Submit written or electronic comments on agency guidance documents at any time. Laurie Burke, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6462, Silver Spring, MD 20993-0002, laurie.burke@fda.hhs.gov, or Guidance for Industry on Indexing Structured Product Labeling; Availability, laurie.burke@fda.hhs.gov spl@fda.hhs.gov http://www.fda.gov/cber/guidelines.htm http://www.fda.gov/cder/guidance/index.htm http://www.fda.regulations http://www.regulations.gov Vol. 73, no. 106 Office of the Federal Register, National Archives and Records Administration 2008-06-02 continuing daily deposited born digital 269 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2008-06-02 P0b002ee1809ace24 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr02jn08 https://www.govinfo.gov/app/details/FR-2008-06-02 https://www.govinfo.gov/content/pkg/FR-2008-06-02/pdf/FR-2008-06-02.pdf https://www.govinfo.gov/content/pkg/FR-2008-06-02/xml/FR-2008-06-02.xml fdlp 31351 31604 DGPO 2010-09-23 2024-06-05 FR-2008-06-02 machine generated eng FR FR-2008-06-02 73 106