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GUIDANCE DOCUMENT

Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products July 1997

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1995-D-0101
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance applies only to specified biotechnology and specified synthetic biological products, including recombinant DNA-derived protein/polypeptide products approved under the FDCA and complexes or conjugates of a drug with a monoclonal antibody approved under the FDCA, or biological products licensed under the Public Health Service (PHS) Act and outlined in 21 CFR 601.2(c). The section on labeling applies only to licensed biological products. This guidance is intended to assist manufacturers in determining which reporting mechanism is appropriate for a change to an approved application for such products.
 

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1995-D-0101.

 
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