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Guidance Issuing OfficeCenter 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.”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.
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-2018-D-3903.