Issue Date: July 1, 1997
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
Status: Final
Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
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.
Download the Guidance Document
