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 1996_register executive 2010-09-24 article Notices D09002ee1be050937 D09002ee1be0509e0 United States Department of Health and Human Services originator org United States Government Agency or Subagency The Food and Drug Administration is publishing a final guideline on the quality of biotechnological products entitled ``Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products.'' The guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guideline is intended to describe the types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant deoxyribonucleic acid (r-DNA) derived proteins. 61 FR 7006 https://www.govinfo.gov/app/details/FR-1996-02-23/96-4064 96-4064 fr23fe96-93 4160-01-F Docket No. 95D-0216 https://www.govinfo.gov/app/details/FR-1996-02-23/96-4064 https://www.govinfo.gov/content/pkg/FR-1996-02-23/html/96-4064.htm https://www.govinfo.gov/content/pkg/FR-1996-02-23/pdf/96-4064.pdf 3 p. 7006 7008 61 FR 7006 International Conference on Harmonisation; Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products; Availability; Federal Register Vol. 61, Issue NOTICE 96-4064 DEPARTMENT OF HEALTH AND HUMAN SERVICES 1996-02-23 Docket No. 95D-0216 4160-01-F 96-4064 Notice.

The Food and Drug Administration is publishing a final guideline on the quality of biotechnological products entitled ``Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products.'' The guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guideline is intended to describe the types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant deoxyribonucleic acid (r-DNA) derived proteins.

Effective February 23, 1996. Submit written comments at any time. Regarding the guideline: Elaine C. Esber, Center for Biologics Evaluation and Research (HFM-30), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0641. Vol. 61, no. 37 Office of the Federal Register, National Archives and Records Administration 1996-02-23 continuing daily deposited born digital 158 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1996-02-23 P0b002ee180a2d355 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr23fe96 https://www.govinfo.gov/app/details/FR-1996-02-23 https://www.govinfo.gov/content/pkg/FR-1996-02-23/pdf/FR-1996-02-23.pdf fdlp 6917 7063 DGPO 2010-09-24 2023-05-07 FR-1996-02-23 machine generated eng FR FR-1996-02-23 61 37