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 2005_register executive 2010-09-23 article Notices D09002ee1c811858a D09002ee1c8118612 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 "Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients." This document is intended to provide guidance on the types of toxicity information that FDA recommends be provided to the agency to support the use of new excipients in drug products. Previously, such information was not available to drug sponsors in a written document. This information should allow drug sponsors to determine if a potential new excipient is safe to use in drug products. 70 FR 28946 https://www.govinfo.gov/app/details/FR-2005-05-19/05-9957 05-9957 fr19my05-75 4160-01-S Docket No. 2002D-0389 https://www.govinfo.gov/app/details/FR-2005-05-19/05-9957 https://www.govinfo.gov/content/pkg/FR-2005-05-19/html/05-9957.htm https://www.govinfo.gov/content/pkg/FR-2005-05-19/pdf/05-9957.pdf 2 p. 28946 28947 70 FR 28946 Guidance for Industry on Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients; Availability; Federal Register Vol. 70, Issue NOTICE 05-9957 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. 2002D-0389 4160-01-S 05-9957 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients." This document is intended to provide guidance on the types of toxicity information that FDA recommends be provided to the agency to support the use of new excipients in drug products. Previously, such information was not available to drug sponsors in a written document. This information should allow drug sponsors to determine if a potential new excipient is safe to use in drug products.

Submit written or electronic comments on agency guidances at any time. For the Center for Drug Evaluation and Research: Robert E. Osterberg, Center for Drug Evaluation and Research (HFD-520), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 2120, or Reports and guidance documents; availability, etc.: Nonclinical Studies for Safety Evaluation of Pharmaceutical Excipients, http://www.fda.gov/cber/guidelines.htm http://www.fda.gov/cder/guidance/index.htm http://www.fda.gov/dockets/ecomments http://www.fda.gov/ohrms/dockets/default.htm Vol. 70, no. 96 Office of the Federal Register, National Archives and Records Administration 2005-05-19 continuing daily deposited born digital 426 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2005-05-19 P0b002ee180993b3c 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr19my05 https://www.govinfo.gov/app/details/FR-2005-05-19 https://www.govinfo.gov/content/pkg/FR-2005-05-19/pdf/FR-2005-05-19.pdf https://www.govinfo.gov/content/pkg/FR-2005-05-19/xml/FR-2005-05-19.xml fdlp 28773 29187 DGPO 2010-09-23 2024-06-06 FR-2005-05-19 machine generated eng FR FR-2005-05-19 70 96