Le Lézard
Classified in: Health
Subjects: FDA, AVO

America's Blood Centers Urges FDA to Continue to Evaluate Impact of New Final Guidance on Platelet Availability


WASHINGTON, Oct. 3, 2019 /PRNewswire/ -- America's Blood Centers (ABC) encourages the Food and Drug Administration (FDA) to continue to assess the impact of the Final Guidance issued on Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion Guidance for Industry. While the Final Guidance took an important step in allowing for an extended implementation period, significant operational complexities remain that could affect patient access to platelets, especially in rural and underserved communities.

America's Blood Centers Logo (PRNewsfoto/America's Blood Centers)

"Hospitals and the patients they serve rely on independent blood centers to collect and distribute a continual, robust supply of blood components, including platelets," said Kate Fry, MBA, CAE, ABC's Chief Executive Officer. "ABC appreciates the continued opportunity to work with the FDA to ensure patient access to life-saving transfusions. We are fully committed to the safety of the U.S. blood supply and wholeheartedly share the FDA's goal of reducing the risk of bacterial contamination in platelets while ensuring a robust supply of this essential blood component."

Currently there is no FDA approved system available for the large volume, delayed sampling (LVDS) option for a 7-day dating period included in the Guidance. As such, ABC encourages the FDA to expeditiously approve a technology to allow blood centers sufficient time to consider this option and time for the ramp-up required by the manufacturer to meet potential market needs. Additional risk-control strategies should be approved that demonstrate safety and promote maximum flexibility.

ABC looks forward to continuing to work with FDA on our shared goal of minimizing the risk of bacterial contamination of platelets without negatively impacting platelet availability.

About America's Blood Centers
Founded in 1962, America's Blood Centers is North America's largest network of community-based, independent blood programs. Recognized by the U.S. Congress for its critical work in patient care and disaster preparedness and response, the federation operates more than 600 blood donor centers providing close to 60 percent of the U.S., and a quarter of the Canadian blood supply.

These blood centers serve more than 150 million people and provide blood products and services to more than 3,500 hospitals and healthcare facilities across North America. Each year, our members help save the lives of nearly 3 million patients. America's Blood Centers' U.S. members are licensed and regulated by the U.S. Food and Drug Administration. Our Canadian member is regulated by Health Canada. America's Blood Centers is not affiliated with the American Red Cross. For more information visit www.AmericasBlood.org.

 

SOURCE America's Blood Centers


These press releases may also interest you

at 07:50
SullivanCotter, the nation's leading independent consulting firm in the assessment and development of total rewards programs and workforce solutions for the health care industry and not-for-profit sector, welcomes new Principal, Amber Duncan. She...

at 07:45
Glooko, the global leader in diabetes data management, announced today that its Mountain View, California and Gothenburg, Sweden sites have received joint ISO 13485:2016 certification from accredited certification body Intertek Testing Services NA...

at 07:45
Dialogue, the leading Canadian telemedicine platform, today announces a groundbreaking partnership with Doctor On Demand, the leading virtual care provider in the United States. Through this partnership, enterprise clients will now have the option to...

at 07:35
Sage Therapeutics , a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, today announced that it plans to advance SAGE-718, a novel,...

at 07:35
Biotia, a health tech company leveraging next-generation DNA sequencing (NGS) and artificial intelligence (AI) software for precision infectious disease detection and diagnosis, today announced an oversubscribed $2.4M seed raise and expanded...

at 07:35
Bristol-Myers Squibb Company today announced clinical results from the QUAZAR AML-001 study, evaluating investigational agent CC-486 as maintenance therapy in a broad population of patients with front-line, newly diagnosed acute myeloid leukemia...



News published on 3 october 2019 at 11:00 and distributed by: