Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products July 1997
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
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-1995-D-0101.