Issue Date: April 7, 2022
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final
Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment
The Food and Drug Administration (FDA or Agency) is announcing the availability of a 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.
Download the Guidance Document
