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# Draft Guide on Hepatitis B Drugs
- URL: https://www.fdaweb.com/draft-guide-on-hepatitis-b-drugs/
- Published: 2018-11-02T12:00:00.000Z
- Updated: 2026-09-15T00:42:13.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142734

*Federal Register* notice: FDA has made available a draft guidance entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.” The document includes general considerations for nonclinical toxicology and virology studies, early phase clinical development, clinical pharmacology assessments, and Phase 3 safety and efficacy trials. It also discusses Phase 3 trial design considerations and efficacy endpoints for developing combination therapies. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-11-02/pdf/2018-23951.pdf?ref=fdaweb.com).