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 2008_register executive 2010-09-22 article Notices D09002ee1c8095717 D09002ee1c80957a3 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 "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 1: Residue on Ignition/Sulphated Ash General Chapter." 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 the results of the ICH Q4B evaluation of the Residue on Ignition/Sulphated Ash General Chapter harmonized text from each of the three pharmacopeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability among these texts from the local regional pharmacopeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions." 73 FR 9576 https://www.govinfo.gov/app/details/FR-2008-02-21/E8-3187 E8-3187 fr21fe08-70 4160-01-S Docket No. FDA-2008-D-0083 (formerly Docket No. 2006D-0296) https://www.govinfo.gov/app/details/FR-2008-02-21/E8-3187 https://www.govinfo.gov/content/pkg/FR-2008-02-21/html/E8-3187.htm https://www.govinfo.gov/content/pkg/FR-2008-02-21/pdf/E8-3187.pdf 2 p. 9576 9577 73 FR 9576 International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex on Residue on Ignition/Sulphated Ash General Chapter; Availability; Federal Register Vol. 73, Issue NOTICE E8-3187 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2008-D-0083 (formerly Docket No. 2006D-0296) 4160-01-S E8-3187 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 1: Residue on Ignition/Sulphated Ash General Chapter." 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 the results of the ICH Q4B evaluation of the Residue on Ignition/Sulphated Ash General Chapter harmonized text from each of the three pharmacopeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability among these texts from the local regional pharmacopeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions."

Submit written or electronic comments on agency guidance at any time. Regarding the guidance: Robert H. King, Sr., Center for Drug Evaluation and Research (HFD-003), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 3542,Silver Spring, MD 20993-0002, 301-796-1242;or International Conference on Harmonisation; Pharmacopoeial Texts for Use in the ICH Regions; Availability, http://www.fda.gov/cber/publications.htm http://www.fda.gov/cder/guidance/index.htm http://www.fda.gov/ohrms/dockets/default.htm http://www.regulations.gov Vol. 73, no. 35 Office of the Federal Register, National Archives and Records Administration 2008-02-21 continuing daily deposited born digital 225 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2008-02-21 P0b002ee180936f62 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21fe08 https://www.govinfo.gov/app/details/FR-2008-02-21 https://www.govinfo.gov/content/pkg/FR-2008-02-21/pdf/FR-2008-02-21.pdf https://www.govinfo.gov/content/pkg/FR-2008-02-21/xml/FR-2008-02-21.xml fdlp 9439 9654 DGPO 2010-09-22 2024-06-05 FR-2008-02-21 machine generated eng FR FR-2008-02-21 73 35