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 2012_register executive 2012-10-06 article Notices D09002ee1c7fc584b D09002ee1c7fc58cc 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 "Acute Bacterial Sinusitis: Developing Drugs for Treatment." This guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for the treatment of acute bacterial sinusitis (ABS). This guidance finalizes the revised draft guidance of the same name issued on October 30, 2007. 77 FR 61417 https://www.govinfo.gov/app/details/FR-2012-10-09/2012-24748 2012-24748 fr09oc12-60 4160-01-P Docket No. FDA-2007-D-0375 (Formerly 2007D-0395) https://www.govinfo.gov/app/details/FR-2012-10-09/2012-24748 https://www.govinfo.gov/content/pkg/FR-2012-10-09/html/2012-24748.htm https://www.govinfo.gov/content/pkg/FR-2012-10-09/pdf/2012-24748.pdf 2 p. 61417 61418 77 FR 61417 Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability; Federal Register Vol. 77, Issue NOTICE 2012-24748 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2007-D-0375 (Formerly 2007D-0395) 4160-01-P 2012-24748 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Acute Bacterial Sinusitis: Developing Drugs for Treatment." This guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for the treatment of acute bacterial sinusitis (ABS). This guidance finalizes the revised draft guidance of the same name issued on October 30, 2007.

Submit either electronic or written comments on Agency guidances at any time. 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. Guidance for Industry; Availability: Acute Bacterial Sinusitis; Developing Drugs for Treatment , http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 77, no. 195 Office of the Federal Register, National Archives and Records Administration 2012-10-09 continuing daily deposited born digital 288 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-10-09 P0b002ee183634945 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr09oc12 https://www.govinfo.gov/app/details/FR-2012-10-09 https://www.govinfo.gov/content/pkg/FR-2012-10-09/pdf/FR-2012-10-09.pdf https://www.govinfo.gov/content/pkg/FR-2012-10-09/xml/FR-2012-10-09.xml fdlp 61229 61506 DGPO 2012-10-06 2024-06-03 FR-2012-10-09 machine generated eng FR FR-2012-10-09 77 195