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# Hepatitis B Drug Development Guidance Out
- URL: https://www.fdaweb.com/hepatitis-b-drug-development-guidance-out/
- Published: 2018-11-01T12:00:00.000Z
- Updated: 2026-09-15T00:42:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142719

FDA has issued a draft guidance, *Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment*, to assist sponsors in the clinical development of drugs and biologics to treat chronic hepatitis B viral infection from IND through NDA/BLA and postmarketing. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM624695.pdf?ref=fdaweb.com) says it will be the focus for continued discussions among the Division of Antiviral Products, drug sponsors, the academic community, and the public. The guidance does not address development of vaccines or blood-derived products, since they are regulated by CBER. It also does not discuss general issues of statistical analysis or clinical trial design.

Contents of the guidance include Introduction, Background, Development Program (general drug development considerations, Phase 3 efficacy trial considerations, and other considerations), Glossary of Acronyms, and References.