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AABB Weekly Report - April 22, 2011

  Visit aabb.org Unsubscribe to this Newsletter April 22, 2011 | Vol. 17 | No. 16
 

IN THIS ISSUE

'Face of Google Health,' TV Journalist to Address AABB's 2011 Annual Meeting »

FDA Releases Guidance on How to Write a 'Request For Designation' »

Plasma for Further Manufacture, Donor Written Statement of Understanding Among Topics at Upcoming BPAC Meeting »

Summary of March FDA Liaison Committee Meeting Now Available »

FDA Tissue Reference Group Releases 2010 Annual Report of Recommendations for Regulation
of HCT/Ps »

NHLBI Announces Funding Opportunity for Clinical Hematology and Transfusion Medicine
Researchers »

Reminder: Just 2 Weeks Remain to Submit Abstract Proposals for 2011 Annual Meeting »

Region Watch »


 

'Face of Google Health,' TV Journalist to Address AABB's 2011 Annual Meeting

Dr. Bob Arnot, the medical doctor who became a news correspondent and international humanitarian, will be the opening session speaker for the 2011 AABB Annual Meeting and CTTXPO in San Diego. Arnot is most recognizable as the former chief medical correspondent "Dr. Bob" on NBC News. As a reporter he covered epidemics such as ebola, HIV/AIDS and cholera in many countries. Most recently, he has worked with Google to produce a series of educational videos on chronic illnesses that are viewable on YouTube, and is the host of the television series "Dr. Danger," during which he travels to some of the world's most dangerous places, highlighting humanitarian issues amid crisis and conflict.

The 2011 AABB Annual Meeting and CTTXPO, which will be held Oct. 22-25, will offer more than 100 educational sessions and a show floor featuring 200 exhibitors. Registration opens in June.

FDA Releases Guidance on How to Write a 'Request For Designation'

The Food and Drug Administration this week released a guidance on how to request from the agency a determination of the regulatory identity or classification of a product as a drug, device, biological product or combination product. Sponsors working with potential combination products — those containing two or more regulated items packaged separately or together — may find this guidance of particular interest, as one issue that is clarified through the "request for designation" process is the FDA center that would have primary jurisdiction for premarket review and regulation if it is a combination product, such as the Center for Biologics Evaluation and Research or the Center for Devices and Radiological Health. The guidance addresses 21 CFR 3.7 and is intended to clarify the type of information the Office of Combination Products recommends that a sponsor include in a request for designation. To avoid expending unnecessary time and resources, sponsors are encouraged to submit the RFD as soon as they have sufficient information for FDA to make a decision regarding classification or assignment of a product. This document supersedes the previous RFD guidance issued in August 2005.

Plasma for Further Manufacture, Donor Written Statement of Understanding Among Topics at Upcoming BPAC Meeting

The Center for Biologics Evaluation and Research of the Food and Drug Administration has released the meeting materials, including the draft agenda and issue summaries, for the April 28-29 meeting of the Blood Products Advisory Committee. According to the issue summaries on the topic of "Plasma for Further Manufacturing Obtained From Whole Blood Donors," FDA will seek advice from BPAC on standards and labeling for two licensed plasma products (concurrent plasma and component plasma) collected under whole blood donor eligibility requirements in 21 CFR 640.3 and labeled for use in further manufacturing to make injectable or non-injectable products; this is a follow-up to the April 2009 BPAC meeting. Finally, BPAC will be asked to advise FDA on the seven proposed elements of the donor written statement of understanding as listed in FDA's 2007 proposed rule for donor eligibility and the best methods to present this information to the donor. The committee also will discuss whether scientific data support the concept that testing source plasma for hepatitis B virus DNA by nucleic acid testing increases the margin of safety of plasma derivatives and whether such detection in donors adds to public health.

Summary of March FDA Liaison Committee Meeting Now Available

A summary of the most recent meeting of the FDA Liaison Committee has been posted on the AABB website. Agenda items for the meeting, held March 30, included screening donors for a history of Chagas' disease, donor safety deviations, draft guidance for leukoreduction of blood components, and the detection of bacterial contamination in platelets. The FDA Liaison Committee includes representatives from AABB, the American Red Cross, America's Blood Centers, Advanced Medical Technology Association, the College of American Pathologists and the Armed Services Blood Program.

FDA Tissue Reference Group Releases 2010 Annual Report of Recommendations for Regulation of HCT/Ps

The Food and Drug Administration's Center for Biologics Evaluation and Research has posted on its website the Tissue Reference Group's fiscal year 2010 annual report of recommendations on the regulation of human cells, tissues, and cellular and tissue-based products. The TRG recommendations — part of the group's mission to help facilities that process HCT/Ps determine the jurisdiction and applicable regulations under which their products fall — reference three HCT/Ps: the fascia lata allograft intended for use for the repair of the anterior cruciate ligament; allogeneic adipose-derived stem cells seeded onto a bone scaffold for filling, augmenting or repair of pathologically or surgically created bony voids; and allogeneic demineralized cortical human bone with alternating large and small sections for use in orthopedic applications.

NHLBI Announces Funding Opportunity for Clinical Hematology and Transfusion Medicine Researchers

The National Heart, Lung and Blood Institute announced April 14 the availability of a K12 physician scientist award for early-career researchers focused on clinical non-malignant hematology and transfusion medicine. The goal of this funding opportunity is to promote the career development and training of fellows and junior faculty health professionals. Application budgets are limited to $370,000 in direct costs per year for a maximum of five years. Submissions for this grant will be accepted for 30 days beginning May 20 and can be submitted electronically through the federal government's grants portal.

Reminder: Just 2 Weeks Remain to Submit Abstract Proposals for 2011 Annual Meeting

Individual members are reminded that they have just two weeks left to submit abstracts to be considered for presentation at the 2011 AABB Annual Meeting and CTTXPO in San Diego. Entries will be accepted through May 4. This year's categories and submission guidelines are available on the AABB website. Abstracts only can be submitted online, where they can be drafted and saved for completion at a later date. Authors of abstracts selected for either oral presentations or poster displays will be notified by June 30. Questions regarding the 2011 abstract program should be directed to AABB's education and professional development department.

Region Watch

Requests for platelet products, cryoprecipitate and most plasma types are quickly addressed due to robust quantities, according to the National Blood Exchange. However, nationwide levels of AB plasma are too low to meet current demand from the U.S. military and some civilian blood centers. Meanwhile, rising quantities of most blood types allow for fast servicing of such requests, but the need for O-negative red blood cells outpaces supply.

AABB, 8101 Glenbrook Road, Bethesda, MD 20814
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Managing Editor:
Sherkiya Wedgeworth

Copyright 2011 AABB. All rights reserved.

 

 

Event Calendar

April 26 – NHLBI Sickle Cell Disease Advisory Committee Meeting read more »

April 27 – AABB Audioconference: Ancillary Materials
read more »

April 28-29 – FDA Blood Products Advisory Committee Meeting read more »

May 3-6 – FDA/Xavier University Global Medical Device Conference
read more »

May 4 – AABB Audioconference: Optimizing the Use of Rare Red Cells in Hematopoietic Cell Transplant Recipients
read more »

May 11 – AABB Audioconference: Effectively Welcoming New Employees read more »

May 11 – HHS Advisory Council on Blood Stem Cell Transplantation Meeting
read more »

May 12-15 – Canadian Society for Transfusion Medicine Conference
read more »

May 17-18 – FDA Workshop to Address Potential Procoagulant Activity in Immune Globulin Intravenous Products read more »

May 18 – AABB Audioconference: Bacterial Contamination of Blood Products read more »

May 25 – AABB Audioconference: Update on Umbilical Cord Blood Banking and Transplantation
read more »

Full Calendar read more »

New Web Resources

FDA Device Approvals: Plasma Donation Data Management System and Point-of-Care Platelet Concentrate
read more »