Document ID: FDA-2010-N-0001-0063
Agency: fda
Document Type: Notice
Title: Issues in Development of Medical Products for Prophylaxis and/or Treatment of Acute Antibody Mediated Rejection in Kidney Transplant Recipients; Public Workshop
Posted Date: 2010-06-08T04:00Z

[Federal Register: June 8, 2010 (Volume 75, Number 109)]
[Notices]               
[Page 32490-32491]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn10-121]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

 
Issues in the Development of Medical Products for the Prophylaxis 
and/or Treatment of Acute Antibody Mediated Rejection in Kidney 
Transplant Recipients; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop regarding scientific issues in clinical development of medical 
products (i.e., human drugs, therapeutic biological products, and 
medical devices) for prophylaxis and/or treatment of acute antibody 
mediated rejection (AMR) in kidney transplant recipients. This public 
workshop is intended to provide information for and gain perspective 
from health care providers, academia, and industry on various aspects 
of development of medical products for prophylaxis and/or treatment of 
acute AMR in kidney transplant recipients, including clinical trial 
design and endpoints. The input from this public workshop will help in 
developing topics for further discussion.
    Date and Time: The public workshop will be held on June 28, 2010, 
from 8 a.m. to 6:30 p.m. and on June 29, 2010, from 8 a.m. to 4 p.m.
    Location: The public workshop will be held at the Crowne Plaza 
Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited 
and available only on a first-come, first-served basis.
    Contacts: Christine Moser or Ramou Mauer, Center for Drug 
Evaluation and Research, Food and Drug Administration, Office of 
Antimicrobial Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209, 
Silver Spring, MD 20993-0002, 301-796-1300 or 301-796-1600.
    Registration: Registration is free for the public workshop. 
Interested parties are encouraged to register early because space is 
limited. Seating will be available on a first-come, first-served basis. 
To register electronically, e-mail registration information (including 
name, title, firm name, address, telephone, and fax number) to 
AMRworkshop@fda.hhs.gov. Persons without access to the Internet can 
call Christine Moser at 301-796-1300 or Ramou Mauer at 301-796-1600 to 
register. Persons needing a sign language interpreter or other special 
accommodations should notify Christine Moser or Ramou Mauer (see 
Contacts) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop 
regarding medical product development for the prophylaxis and/or 
treatment of acute AMR in kidney transplant recipients. This public 
workshop will focus on scientific considerations in the clinical 
development of medical products for prophylaxis and/or treatment of 
acute AMR in kidney transplant recipients, including the following 
topics:
     Definition and diagnosis of acute AMR
     Importance of validation and standardization of devices 
and diagnostic testing to establish the diagnosis of AMR and to 
identify patients at high risk of AMR
     Results of clinical trials evaluating treatment of acute 
AMR
     Endpoints to be evaluated to assess outcome
     Outcomes achieved with currently used regimens
Additional discussion will include animal models in AMR, previous 
experiences in desensitization and prophylaxis of AMR, and chronic AMR.
    The agency encourages individuals, patient advocates, industry, 
consumer groups, health care professionals, researchers, and other 
interested persons to attend this public workshop.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (HFA-305), Food and 
Drug

[[Page 32491]]

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. Transcripts will also be available 
on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm206132.htm 
approximately 45 days after the workshop.

    Dated: June 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13669 Filed 6-7-10; 8:45 am]
BILLING CODE 4160-01-S