Skip to Content

Notice

Drug-Induced Liver Injury: Are We Ready to Look?; Public Conference; Request for Comments

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public conference; request for comments.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a public conference entitled “Drug-Induced Liver Injury: Are We Ready to Look?” The public conference will be cosponsored with the American Association for the Study of Liver Diseases (AASLD) and the Pharmaceutical and Research Manufacturers of America to discuss and debate issues regarding drug-induced liver injury (DILI). The purpose of this conference is to consider the effect of the recommendations in the guidance for industry entitled “Drug-Induced Liver Injury: Premarketing Clinical Evaluation” since its publication in July 2009 and to seek suggestions for future revision.

DATES:

The public conference will be held on March 23, 2011, from 8 a.m. to 6 p.m. and March 24, 2011, from 8 a.m. until 3:30 p.m. Submit either electronic or written comments on Agency guidance at any time.

ADDRESSES:

The conference will take place at the National Labor College, 10000 New Hampshire Ave., Silver Spring, MD 20993.

Submit written requests for single copies of the 2009 guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the 2009 guidance document.

Submit electronic comments on the 2009 guidance and the issues and questions presented at the conference to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Lana L. Pauls, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4307, Silver Spring, MD 20993-0002, 301-796-0518, e-mail: lana.pauls@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Background

In July 2009, FDA made available a guidance for industry entitled “Drug-Induced Liver Injury: Premarketing Clinical Evaluation” (see 74 FR 38035, July 30, 2009). The 2009 guidance explains that DILI has been the most frequent cause of safety-related drug marketing withdrawals for the past 50 years, and that hepatoxicity has limited the use of many drugs that have been approved and prevented the approval of others. It discusses methods of detecting DILI by periodic tests of serum enzyme activities and bilirubin concentration elevations, and how those laboratory tests might change over time, along with symptoms and physical findings, to allow estimation of severity of the injury. It suggests some rules for stopping or interrupting drug treatment, and the need to obtain additional clinical information to estimate the likelihood of the true cause. Public comments on the draft guidance were sought in 2007 and 2008, and those comments were taken into consideration when issuing the final guidance in July 2009.

II. The Public Conference

A. Why are we holding this conference?

The purpose of the 2011 conference is to discuss the most current information and thinking about how drugs cause liver injury and why certain individuals are more susceptible than others, combining views of both basic science and clinical experts, and selecting for specific debate and discussion issues such as:

  • Liver injury and dysfunction in patients,
  • Liver reaction to injury,
  • Biomarkers and predictors of liver injury and dysfunction, and
  • Postmarketing DILI.Start Printed Page 4919

B. Is there a fee and how do I register for the conference?

A registration fee will be charged to attendees other than invited speakers to help defray the costs of rental of the meeting spaces, meals and snacks provided, and if possible, to cover travel costs incurred by invited academic (but not Government or industry) speakers, and other costs. The fee for the 2-day meeting is $500 for industry registrants and $250 for Federal Government and academic registrants. Registration fees will be waived for invited speakers and moderators.

The registration process will be handled by AASLD, a not-for-profit organization with extensive experience in planning, organizing, and executing educational meetings.

Additional information on the conference, program, and registration procedures is available on the Internet at http://www.aasld.org (go to Conferences and Education, Meetings and Conferences), and also at http://www.fda.gov by typing into the search box “liver toxicity.” (FDA has verified the AASLD Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)

Transcripts: The presentations and discussions will be transcribed and published on the Internet at http://www.aasld.org for public availability after minor editing by the organizers of the meeting (Lana Pauls and John Senior). Please be advised that as soon as a transcript is available, it will also be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding the guidance and the issues and questions presented at the conference. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this notice. Received comments may be seen in the Division of Dockets Management between 9 a.m. Monday through 4 p.m. Friday.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or http://www.regulations.gov.

Start Signature

Dated: January 19, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2011-1759 Filed 1-26-11; 8:45 am]

BILLING CODE 4160-01-P