Document ID: FDA-2012-N-0001-0093
Agency: fda
Document Type: Notice
Title: Gastroenterology Regulatory Endpoints and the Advancement of Therapeuticss (GREAT); Public Workshop
Posted Date: 2012-08-03T04:00Z

[Federal Register Volume 77, Number 150 (Friday, August 3, 2012)]
[Notices]
[Page 46444]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19036]

[[Page 46444]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Gastroenterology Regulatory Endpoints and the Advancement of 
Therapeutics (GREAT); Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration's (FDA) Center for Drug 
Evaluation and Research is announcing a 4-day public workshop entitled 
``Gastroenterology Regulatory Endpoints and the Advancement of 
Therapeutics (GREAT).'' The purpose of this workshop is to provide a 
forum to consider issues related to endpoints that can support drug 
development in the following disease areas: Eosinophilic esophagitis, 
pediatric and adult inflammatory bowel disease, and parenteral 
nutrition-associated liver disease.

DATES: The public workshop will be held on September 19, 20, 21, and 
24, 2012, from 8:30 a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at the Holiday Inn, 10000 
Baltimore Ave., College Park, MD 20740.

FOR FURTHER INFORMATION CONTACT: Kevin Bugin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-2302, FAX: 301-
796-9905, Kevin.Bugin@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 
    This workshop will address endpoints for registration trials. 
Stakeholders, including industry sponsors, academia, and FDA, will be 
engaged to address challenging issues related to selection of endpoints 
and assessment methodologies in registration trials. Facilitation of 
efficient drug development, in the context of these issues, will be 
discussed.
    Each day of the workshop will be devoted to a discussion of a 
single relevant disease area. The goal of the workshop day dedicated to 
eosinophilic esophagitis is to discuss its natural history, development 
of patient reported outcome measures, and biomarkers that might be used 
to study new treatments for both children and adults. The goal of the 
workshop day dedicated to pediatric inflammatory bowel disease (IBD) is 
to discuss issues related to the extrapolation of efficacy data from 
adult to pediatric patients, the definition and measurement of 
treatment benefit, and dose-finding strategies in pediatric patients. 
The goal of the workshop day dedicated to adult IBD is to discuss the 
definition and measurement of efficacy in adult ulcerative colitis 
registration trials, including the timing of endpoint assessment and 
the roles of specific endpoints and measurement tools. The goal of the 
workshop day dedicated to parenteral nutrition-induced liver disease is 
to discuss endpoints and their measurement for clinical trials in which 
parenteral nutrition-induced liver disease is either an efficacy or 
safety outcome measure.
    Particpation In the Public Workshop:
    Registration: There is no fee to attend the public workshop, but 
attendees must register in advance. Space is limited, and registration 
will be on a first-come, first-served basis. Persons interested in 
attending this workshop must register online at http://www.fda.contractmeetings.com before September 1, 2012. For those 
without Internet access, please contact Ann Brameyer (7910 Woodmont 
Ave., suite 310, Bethesda, MD 20814, Phone: 240-316-3205, FAX: 240-316-
3201) to register. Onsite registration will not be available.
    If you need special accommodations due to a disability, please 
contact Kevin Bugin (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance.
    Transcripts:
    Transcripts of the workshop will be available for review at the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and on the Internet 
at http://www.regulations.gov approximately 30 days after the workshop. 
A transcript will also be available in either hard copy or on CD-ROM, 
after submission of a Freedom of Information request. Send written 
requests to the Division of Freedom of Information (ELEM-1029), Food 
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, 
MD 20857. Send faxed requests to 301-827-9267.

    Dated: July 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19036 Filed 8-2-12; 8:45 am]
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