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2018-11-02
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Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Notices
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D09002ee1bdb84992
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.'' 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.
83 FR 55187
https://www.govinfo.gov/app/details/FR-2018-11-02/2018-23951
2018-23951
fr02no18-65
4164-01-P
Docket No. FDA-2018-D-3903
https://www.govinfo.gov/app/details/FR-2018-11-02/2018-23951
https://www.govinfo.gov/content/pkg/FR-2018-11-02/html/2018-23951.htm
https://www.govinfo.gov/content/pkg/FR-2018-11-02/pdf/2018-23951.pdf
2 p.
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83 FR 55187
Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment; Draft Guidance for Industry; Availability; Federal Register Vol. 83, Issue
NOTICE
2018-23951
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-01-02
Docket No. FDA-2018-D-3903
4164-01-P
2018-23951
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.'' 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.
Submit either electronic or written comments on the draft guidance by January 2, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Poonam Mishra, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6100, Silver Spring, MD 20993, 301-796- 1500.
Guidance:
Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment
,
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 83, no. 213
Office of the Federal Register, National Archives and Records Administration
2018-11-02
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162 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2018-11-02
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0042-1219
0364-1406
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000582072
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https://www.govinfo.gov/app/details/FR-2018-11-02
https://www.govinfo.gov/content/pkg/FR-2018-11-02/pdf/FR-2018-11-02.pdf
https://www.govinfo.gov/content/pkg/FR-2018-11-02/xml/FR-2018-11-02.xml
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