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# Hepatitis B Drug Development Guidance
- URL: https://www.fdaweb.com/hepatitis-b-drug-development-guidance/
- Published: 2022-04-06T12:00:00.000Z
- Updated: 2026-09-14T17:39:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151529

FDA has published a 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 infection from the initial IND through the NDA or BLA and postmarketing phases. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/chronic-hepatitis-b-virus-infection-developing-drugs-treatment?ref=fdaweb.com) does not address the development of vaccines or blood-derived products and also does not discuss general issues of statistical analysis or clinical trial design.