Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment

On 6 April 2022 the FDA published the final guidance on developing drugs for chronic hepatitis B virus infection.

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 post-marketing phases.

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