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 2014-05-07 article Notices D09002ee1c7fa1b57 D09002ee1c7fa1bd5 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United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Hospital- Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment." The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antibacterial drugs for the treatment of hospital- acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). The science of clinical trial design and our understanding of this disease have advanced in recent years, and this draft guidance informs sponsors of our current recommendations for clinical development. FDA is specifically requesting comment on critical areas of scientific interest including the appropriate primary efficacy endpoints, the use of an intent-to-treat (ITT) population for the primary analysis population, and the use of antibacterial therapy by patients before participating in clinical trials. This draft guidance revises the draft guidance of the same name that published November 29, 2010. 79 FR 26257 https://www.govinfo.gov/app/details/FR-2014-05-07/2014-10409 2014-10409 fr07my14-66 4160-01-P Docket No. FDA-2010-D-0589 https://www.govinfo.gov/app/details/FR-2014-05-07/2014-10409 https://www.govinfo.gov/content/pkg/FR-2014-05-07/html/2014-10409.htm https://www.govinfo.gov/content/pkg/FR-2014-05-07/pdf/2014-10409.pdf 2 p. 26257 26258 79 FR 26257 Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Availability; Federal Register Vol. 79, Issue NOTICE 2014-10409 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2010-D-0589 4160-01-P 2014-10409 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Hospital- Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment." The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antibacterial drugs for the treatment of hospital- acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). The science of clinical trial design and our understanding of this disease have advanced in recent years, and this draft guidance informs sponsors of our current recommendations for clinical development. FDA is specifically requesting comment on critical areas of scientific interest including the appropriate primary efficacy endpoints, the use of an intent-to-treat (ITT) population for the primary analysis population, and the use of antibacterial therapy by patients before participating in clinical trials. This draft guidance revises the draft guidance of the same name that published November 29, 2010.

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 August 5, 2014. 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 Guidances for Industry; Availability: Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia; Drug Development for Treatment , http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 79, no. 88 Office of the Federal Register, National Archives and Records Administration 2014-05-07 continuing daily deposited born digital 260 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-05-07 P0b002ee1886c648f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr07my14 https://www.govinfo.gov/app/details/FR-2014-05-07 https://www.govinfo.gov/content/pkg/FR-2014-05-07/pdf/FR-2014-05-07.pdf https://www.govinfo.gov/content/pkg/FR-2014-05-07/xml/FR-2014-05-07.xml fdlp 26109 26358 DGPO 2014-05-07 2024-06-02 FR-2014-05-07 machine generated eng FR FR-2014-05-07 79 88