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2019-11-01
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Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Notices
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D09002ee1bdb6b0cf
United States
Department of Health and Human Services
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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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in all phases of development of antiviral drugs for the treatment of chronic hepatitis D virus (HDV) infection. This guidance is intended to provide consistent FDA advice to stakeholders regarding HDV drug development strategies.
84 FR 58724
https://www.govinfo.gov/app/details/FR-2019-11-01/2019-23926
2019-23926
fr01no19-72
4164-01-P
Docket No. FDA-2019-D-4042
https://www.govinfo.gov/app/details/FR-2019-11-01/2019-23926
https://www.govinfo.gov/content/pkg/FR-2019-11-01/html/2019-23926.htm
https://www.govinfo.gov/content/pkg/FR-2019-11-01/pdf/2019-23926.pdf
3 p.
58724
58726
84 FR 58724
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment; Draft Guidance for Industry; Availability; Federal Register Vol. 84, Issue
NOTICE
2019-23926
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-12-31
Docket No. FDA-2019-D-4042
4164-01-P
2019-23926
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in all phases of development of antiviral drugs for the treatment of chronic hepatitis D virus (HDV) infection. This guidance is intended to provide consistent FDA advice to stakeholders regarding HDV drug development strategies.
Submit either electronic or written comments on the draft guidance by December 31, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Aimee Hodowanec, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6341, Silver Spring, MD 20993-0002, 240- 402-5752.
Guidance:
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment
,
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.fda.gov/media/109951/download
https://www.fda.gov/media/86377/download
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 212
Office of the Federal Register, National Archives and Records Administration
2019-11-01
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699 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-11-01
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0042-1219
0364-1406
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https://www.govinfo.gov/app/details/FR-2019-11-01
https://www.govinfo.gov/content/pkg/FR-2019-11-01/pdf/FR-2019-11-01.pdf
https://www.govinfo.gov/content/pkg/FR-2019-11-01/xml/FR-2019-11-01.xml
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