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GUIDANCE DOCUMENT

Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment November 2018

Final

Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment

Docket Number:
FDA-2018-D-3903
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of drugs and biologics for the treatment of chronic hepatitis B virus (HBV) infection from the initial investigational new drug application (IND) through the new drug application (NDA)/biologics license application (BLA) and postmarketing phases.


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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:

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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-2018-D-3903.