2010-13669. 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.

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 [e-mail]. 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 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.