FDA发布人用单克隆抗体产品生产与检测考虑要点最终指南，取代1994年版

GUIDANCE DOCUMENT

Final

Docket Number:

FDA-1994-D-0318

Issued by:

Guidance Issuing Office

Center for Biologics Evaluation and Research

Center for Drug Evaluation and Research

Points to Consider documents provide a flexible approach in which FDA provides and updates its guidance on regulatory issues in many areas of drug development. Such documents are particularly useful in the rapidly evolving field of biotechnology-derived drugs and other biologics. The Center for Biologics Evaluation and Research (CBER) set out to revise the "Points to Consider (PTC) in the Manufacture and Testing of Monoclonal Antibody Products for Human Use" with several objectives. An important goal was to facilitate initial development of monoclonal antibodies for serious or life threatening indications.  Additionally, it was felt that some of the information in the 1994 document required updating and streamlining. Finally, it was necessary to review this document for consistency with current CBER policy and with International Conference on Harmonisation (ICH) documents dealing with this category of products. This updated document supersedes the 1994 version, and is designed to assist sponsors and investigators regarding monoclonal antibody (mAb) product development, including information to submit when filing Investigational New Drug Applications ("INDs") and License Applications.  Although this document does not create or confer any rights for or on any person and does not operate to bind FDA or the public, it does represent the agency’s current thinking on monoclonal antibody products for human use.

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If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1994-D-0318.