Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment | Guideline Explorer

Description

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.” This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Scope & Applicability

Product Classes

2

In vitro diagnostic

Used for patient management or selection in a clinical trial

Investigational drugs

In case of investigational drugs, provide as much information as known.

Stakeholders

2

Sponsor

Entity responsible for submitting applications under section 524B

Expert Committee

Body to adjudicate hepatic decompensation and cardiac events

Regulatory Context

Attributes

3

Biomarker

Biological indicator used to select patient populations

Accelerated approval

Regulatory pathway supported by histological improvements as surrogate endpoints.

Exposure-Response Information

Critical data for future extrapolation to pediatric populations

Identified Hazards

Hazards

1

Liver toxicity

Potential risk based on animal toxicology studies requiring safety monitoring.

Related CFR Sections (2)

21CFR314.500§ 314.500 Scope.
This subpart applies to certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intoRead full regulation →
21CFR601.40§ 601.40 Scope.
This subpart applies to certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or inRead full regulation →