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Chronic hepatitis B virus infection: developing drugs for treatment
Chronic hepatitis B virus infection: developing drugs for treatment
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body. - Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Approval
Drug Development
Hepatitis B -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration - Genre(s):
- Technical Report
- Abstract:
- 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.2 Sponsors are also encouraged to communicate with the Division of Antivirals through the pre-IND consultation program to obtain advice in the development of drugs with unique considerations based on mechanism of action, novel treatment approaches, or the use of novel biomarkers.3 This guidance does not address development of vaccines or blood-derived products, which are regulated by the Center for Biologics Evaluation and Research. This guidance also does not discuss general issues of statistical analysis or clinical trial design. Those topics are addressed in the ICH guidances for industry E9 Statistical Principles for Clinical Trials (September 1998) and E10 Choice of Control Group and Related Issues in Clinical Trials (May 2001), respectively.4 The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (25 pages)).
- NLM Unique ID:
- 9918452387906676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918452387906676