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 2012-09-29 article Notices D09002ee1c7fc5fe8 D09002ee1c7fc60a4 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United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Complicated Intra-Abdominal Infections: Developing Drugs for Treatment." The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated intra-abdominal infections (cIAIs). Specifically, this guidance addresses FDA's current thinking regarding the overall drug development program for the treatment of cIAIs, including clinical trial designs to support approval of drugs. 77 FR 59928 https://www.govinfo.gov/app/details/FR-2012-10-01/2012-24036 2012-24036 fr01oc12-84 4160-01-P Docket No. FDA-2012-D-0973 https://www.govinfo.gov/app/details/FR-2012-10-01/2012-24036 https://www.govinfo.gov/content/pkg/FR-2012-10-01/html/2012-24036.htm https://www.govinfo.gov/content/pkg/FR-2012-10-01/pdf/2012-24036.pdf 2 p. 59928 59929 77 FR 59928 Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for Treatment; Availability; Federal Register Vol. 77, Issue NOTICE 2012-24036 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-D-0973 4160-01-P 2012-24036 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Complicated Intra-Abdominal Infections: Developing Drugs for Treatment." The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated intra-abdominal infections (cIAIs). Specifically, this guidance addresses FDA's current thinking regarding the overall drug development program for the treatment of cIAIs, including clinical trial designs to support approval of drugs.

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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 31, 2012. 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: Developing Drugs for Treatment of Complicated Intra-Abdominal Infections , http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 77, no. 190 Office of the Federal Register, National Archives and Records Administration 2012-10-01 continuing daily deposited born digital 331 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-10-01 P0b002ee1835ed539 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr01oc12 https://www.govinfo.gov/app/details/FR-2012-10-01 https://www.govinfo.gov/content/pkg/FR-2012-10-01/pdf/FR-2012-10-01.pdf https://www.govinfo.gov/content/pkg/FR-2012-10-01/xml/FR-2012-10-01.xml fdlp 59709 60028 DGPO 2012-09-29 2024-06-03 FR-2012-10-01 machine generated eng FR FR-2012-10-01 77 190