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Bispecific Antibody Development Programs Guidance for Industry April 2019

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center 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.

Submit Comments

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:

Dockets Management
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.

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