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 2004_register executive 2010-09-23 article Notices D09002ee1c815c49f D09002ee1c815c53b 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 "Q1E Evaluation of Stability Data." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance is a supplement to an ICH guidance entitled "Q1A(R2) Stability Testing of New Drug Substances and Products," which was revised from Q1A(R) and published in the Federal Register of November 21, 2003 (68 FR 65717). It is intended to provide guidance on how to use stability data, generated in accordance with the principles outlined in Q1A(R2), to propose a retest period for the drug substance and a shelf life for the drug product. 69 FR 32010 https://www.govinfo.gov/app/details/FR-2004-06-08/04-12889 04-12889 fr08jn04-75 4160-01-S Docket No. 2002D-0237 https://www.govinfo.gov/app/details/FR-2004-06-08/04-12889 https://www.govinfo.gov/content/pkg/FR-2004-06-08/html/04-12889.htm https://www.govinfo.gov/content/pkg/FR-2004-06-08/pdf/04-12889.pdf 2 p. 32010 32011 69 FR 32010 International Conference on Harmonisation; Evaluation of Stability Data; Availability; Federal Register Vol. 69, Issue NOTICE 04-12889 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2004-06-08 Docket No. 2002D-0237 4160-01-S 04-12889 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q1E Evaluation of Stability Data." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance is a supplement to an ICH guidance entitled "Q1A(R2) Stability Testing of New Drug Substances and Products," which was revised from Q1A(R) and published in the Federal Register of November 21, 2003 (68 FR 65717). It is intended to provide guidance on how to use stability data, generated in accordance with the principles outlined in Q1A(R2), to propose a retest period for the drug substance and a shelf life for the drug product.

The guidance is effective June 8, 2004. Submit written or electronic comments at any time. Regarding the guidance: Chi-wan Chen, Center for Drug Evaluation and Research (HFD-830), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2001; or Andrew Shrake, Center for Biologics Evaluation and Research (HFM-345), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1148, 301-402- 4635. Harmonisation International Conference; guidelines availability: Identity standards deviation; market testing permits Stability data; Q1E evaluation, http://www.fda.gov/cber/publications.htm http://www.fda.gov/cder/guidance/index.htm http://www.fda.gov/dockets/ecomments http://www.fda.gov/ohrms/dockets/default.htm Vol. 69, no. 110 Office of the Federal Register, National Archives and Records Administration 2004-06-08 continuing daily deposited born digital 387 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2004-06-08 P0b002ee1809708bc 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr08jn04 https://www.govinfo.gov/app/details/FR-2004-06-08 https://www.govinfo.gov/content/pkg/FR-2004-06-08/pdf/FR-2004-06-08.pdf https://www.govinfo.gov/content/pkg/FR-2004-06-08/xml/FR-2004-06-08.xml fdlp 31867 32245 DGPO 2010-09-23 2024-06-06 FR-2004-06-08 machine generated eng FR FR-2004-06-08 69 110