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2018-12-04
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Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Notices
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D09002ee1c1729276
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.'' This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
83 FR 62582
https://www.govinfo.gov/app/details/FR-2018-12-04/2018-26333
2018-26333
fr04de18-52
4164-01-P
Docket No. FDA-2018-D-3632
https://www.govinfo.gov/app/details/FR-2018-12-04/2018-26333
https://www.govinfo.gov/content/pkg/FR-2018-12-04/html/2018-26333.htm
https://www.govinfo.gov/content/pkg/FR-2018-12-04/pdf/2018-26333.pdf
2 p.
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83 FR 62582
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability; Federal Register Vol. 83, Issue
NOTICE
2018-26333
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-02-04
Docket No. FDA-2018-D-3632
4164-01-P
2018-26333
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.'' This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
Submit either electronic or written comments on the draft guidance by February 4, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Evangela Covert, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5234, Silver Spring, MD 20993-0002, 301- 796-4075.
Guidance:
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: 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. 233
Office of the Federal Register, National Archives and Records Administration
2018-12-04
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247 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2018-12-04
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https://www.govinfo.gov/app/details/FR-2018-12-04
https://www.govinfo.gov/content/pkg/FR-2018-12-04/pdf/FR-2018-12-04.pdf
https://www.govinfo.gov/content/pkg/FR-2018-12-04/xml/FR-2018-12-04.xml
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