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Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry November 2019

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Not for implementation.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This guidance is being distributed for comment purposes only.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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-2019-D-4042

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of chronic hepatitis D virus (HDV) infection. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current recommendations regarding the overall development program and clinical trial designs for the development of drugs and biologics to support an indication for the treatment of chronic HDV infection.

FDA encourages sponsors to communicate with the Division of Antiviral Products (DAVP) through the pre-investigational new drug application (pre-IND) consultation program to discuss the development of drugs with unique considerations based on mechanism of action, novel treatment approaches, or the use of novel biomarkers. This draft guidance is intended to serve as a focus for continued discussions among DAVP, pharmaceutical sponsors, the academic community, and the public.