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 2014-12-10 article Notices D09002ee1c7f82972 D09002ee1c7f829ef 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 the Agency) is announcing the availability of a guidance for industry entitled "Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products--Content and Format." The recommendations in this guidance are intended to assist applicants in developing the "Patient Counseling Information" section of labeling and to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format. This guidance finalizes the draft guidance issued on September 18, 2013. 79 FR 73322 https://www.govinfo.gov/app/details/FR-2014-12-10/2014-28888 2014-28888 fr10de14-62 4164-01-P Docket No. FDA-2013-D-1067 https://www.govinfo.gov/app/details/FR-2014-12-10/2014-28888 https://www.govinfo.gov/content/pkg/FR-2014-12-10/html/2014-28888.htm https://www.govinfo.gov/content/pkg/FR-2014-12-10/pdf/2014-28888.pdf 2 p. 73322 73323 79 FR 73322 Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Guidance for Industry; Availability; Federal Register Vol. 79, Issue NOTICE 2014-28888 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2013-D-1067 4164-01-P 2014-28888 Notice.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled "Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products--Content and Format." The recommendations in this guidance are intended to assist applicants in developing the "Patient Counseling Information" section of labeling and to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format. This guidance finalizes the draft guidance issued on September 18, 2013.

Submit either electronic or written comments on Agency guidances at any time. Jonas Santiago, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6348, Silver Spring, MD 20993-0002, 301- 796-5346; or 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. Guidance: Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products; Content and Format , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084159.htm http://www.regulations.gov Vol. 79, no. 237 Office of the Federal Register, National Archives and Records Administration 2014-12-10 continuing daily deposited born digital 278 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-12-10 P0b002ee18a701c86 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr10de14 https://www.govinfo.gov/app/details/FR-2014-12-10 https://www.govinfo.gov/content/pkg/FR-2014-12-10/pdf/FR-2014-12-10.pdf https://www.govinfo.gov/content/pkg/FR-2014-12-10/xml/FR-2014-12-10.xml fdlp 73191 73460 DGPO 2014-12-10 2024-06-02 FR-2014-12-10 machine generated eng FR FR-2014-12-10 79 237