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 1997_register executive 2010-09-24 article Notices D09002ee1be023cb1 D09002ee1be023d24 United States Department of Health and Human Services originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a points to consider (PTC) document entitled ``Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (1997).'' This PTC document is intended to assist sponsors and investigators engaged in monoclonal antibody product development and it includes information to submit when filing investigational new drug applications and product license applications. The document revises a 1994 document entitled ``Draft Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use.'' 62 FR 9196 https://www.govinfo.gov/app/details/FR-1997-02-28/97-5006 97-5006 fr28fe97-65 4160-01-F Docket No. 94D-0259 https://www.govinfo.gov/app/details/FR-1997-02-28/97-5006 https://www.govinfo.gov/content/pkg/FR-1997-02-28/html/97-5006.htm https://www.govinfo.gov/content/pkg/FR-1997-02-28/pdf/97-5006.pdf 2 p. 9196 9197 62 FR 9196 ``Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (1997);'' Availability; Federal Register Vol. 62, Issue NOTICE 97-5006 DEPARTMENT OF HEALTH AND HUMAN SERVICES Docket No. 94D-0259 4160-01-F 97-5006 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a points to consider (PTC) document entitled ``Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (1997).'' This PTC document is intended to assist sponsors and investigators engaged in monoclonal antibody product development and it includes information to submit when filing investigational new drug applications and product license applications. The document revises a 1994 document entitled ``Draft Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use.''

Written comments may be submitted at any time. Sharon A. Carayiannis, Center for Biologics Evaluation and Research (HFM-630), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594- 3074. Vol. 62, no. 40 Office of the Federal Register, National Archives and Records Administration 1997-02-28 continuing daily deposited born digital 287 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1997-02-28 P0b002ee180a47cc6 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr28fe97 https://www.govinfo.gov/app/details/FR-1997-02-28 https://www.govinfo.gov/content/pkg/FR-1997-02-28/pdf/FR-1997-02-28.pdf fdlp 9071 9347 DGPO 2010-09-24 2023-05-06 FR-1997-02-28 machine generated eng FR FR-1997-02-28 62 40