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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.