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 2013_register executive 2013-11-06 article Notices D09002ee1c7facfb0 D09002ee1c7fad021 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United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Pulmonary Tuberculosis: Developing Drugs for Treatment." The purpose of the draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the development of a single investigational drug as well as development of two or more unmarketed investigational drugs for use in combination. 78 FR 66744 https://www.govinfo.gov/app/details/FR-2013-11-06/2013-26549 2013-26549 fr06no13-43 4160-01-P Docket No. FDA-2013-D-1319 https://www.govinfo.gov/app/details/FR-2013-11-06/2013-26549 https://www.govinfo.gov/content/pkg/FR-2013-11-06/html/2013-26549.htm https://www.govinfo.gov/content/pkg/FR-2013-11-06/pdf/2013-26549.pdf 2 p. 66744 66745 78 FR 66744 Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability; Federal Register Vol. 78, Issue NOTICE 2013-26549 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2013-D-1319 4160-01-P 2013-26549 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Pulmonary Tuberculosis: Developing Drugs for Treatment." The purpose of the draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the development of a single investigational drug as well as development of two or more unmarketed investigational drugs for use in combination.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 4, 2014. Eileen Navarro, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6126, Silver Spring, MD 20993-0002, 301- 796-1300; or Joseph G. Toerner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301-796-1300. Draft Guidance for Industry; Availability: Pulmonary Tuberculosis; Developing Drugs for Treatment , http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 78, no. 215 Office of the Federal Register, National Archives and Records Administration 2013-11-06 continuing daily deposited born digital 213 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-11-06 P0b002ee18650170b 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr06no13 https://www.govinfo.gov/app/details/FR-2013-11-06 https://www.govinfo.gov/content/pkg/FR-2013-11-06/pdf/FR-2013-11-06.pdf https://www.govinfo.gov/content/pkg/FR-2013-11-06/xml/FR-2013-11-06.xml fdlp 66621 66824 DGPO 2013-11-06 2024-06-03 FR-2013-11-06 machine generated eng FR FR-2013-11-06 78 215