- Docket Number:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance provides recommendations to assist industry and other parties involved in the 17 development of bispecific antibodies. Discussion includes general considerations and 18 recommendations for bispecific antibody development programs, as well as regulatory, quality, 19 nonclinical, and clinical considerations in the context of bispecific antibody development 20 programs. This guidance does not discuss development considerations for other multitarget 21 therapies that are combinations of monoclonal antibodies or are antibody cocktails or polyclonal antibodies. 2 22 Although this guidance is specific to bispecific antibodies, the principles discussed 23 in this guidance may also be applicable to the development of other types of bispecific protein 24 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-2019-D-0621.