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GUIDANCE DOCUMENT

Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry Draft Guidance for Industry July 2021

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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-2021-D-0519


Docket Number:
FDA-2021-D-0519
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to help sponsors in the development of anti-rabies virus monoclonal antibody (mAb) cocktails as an alternative to anti-rabies virus immunoglobulin (RIG) as the passive immunization component of post-exposure prophylaxis (PEP) for the prevention of rabies when given immediately after contact with a rabid or possibly rabid animal. This draft guidance is intended to serve as a focus for continued discussions among the Division of Antivirals, sponsors, the academic community, and the public. This guidance does not address the development of rabies vaccines, products to treat rabies, or mAbs for other indications. The recommendations in this guidance relate to studies to be submitted in support of a biologics license application (BLA) submission under section 351 of the Public Health Service Act (42 U.S.C. § 262) and implementing regulations at 21 CFR part 601.

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