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 2010_register executive 2010-03-06 article Notices D09002ee1c8025e2d D09002ee1c8025eaa 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 entitled "S9 Nonclinical Evaluation for Anticancer Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both drugs and biotechnology derived products, intended to treat patients with advanced cancer. The recommendations describe the type and timing of nonclinical studies to support an investigational new drug application (IND) and the submission of a new drug application (NDA) or biologics license application (BLA). The guidance is intended to provide information on internationally accepted recommendations for nonclinical studies to facilitate the development of anticancer pharmaceuticals. 75 FR 10487 https://www.govinfo.gov/app/details/FR-2010-03-08/2010-4841 2010-4841 FR08MR10-54 4160-01-S Docket No. FDA-2009-D-0006 https://www.govinfo.gov/app/details/FR-2010-03-08/2010-4841 https://www.govinfo.gov/content/pkg/FR-2010-03-08/html/2010-4841.htm https://www.govinfo.gov/content/pkg/FR-2010-03-08/pdf/2010-4841.pdf 2 p. 10487 10488 75 FR 10487 International Conference on Harmonisation; Guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability; Federal Register Vol. 75, Issue NOTICE 2010-4841 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2009-D-0006 4160-01-S 2010-4841 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S9 Nonclinical Evaluation for Anticancer Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both drugs and biotechnology derived products, intended to treat patients with advanced cancer. The recommendations describe the type and timing of nonclinical studies to support an investigational new drug application (IND) and the submission of a new drug application (NDA) or biologics license application (BLA). The guidance is intended to provide information on internationally accepted recommendations for nonclinical studies to facilitate the development of anticancer pharmaceuticals.

Submit written or electronic comments on agency guidance at any time. Regarding the guidance: John K. Leighton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 22, rm. 2204, Silver Spring, MD 20993-0002, 301-796-2330; or Mercedes Serabian, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-5377. Guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability: International Conference on Harmonisation , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 75, no. 44 Office of the Federal Register, National Archives and Records Administration 2010-03-08 continuing daily deposited born digital 231 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2010-03-08 P0b002ee1801ae95e 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:FR08MR10 https://www.govinfo.gov/app/details/FR-2010-03-08 https://www.govinfo.gov/content/pkg/FR-2010-03-08/pdf/FR-2010-03-08.pdf https://www.govinfo.gov/content/pkg/FR-2010-03-08/xml/FR-2010-03-08.xml fdlp 10409 10630 DGPO 2010-03-06 2024-06-04 FR-2010-03-08 machine generated eng FR FR-2010-03-08 75 44