These joint comments from AABB, America’s Blood Centers, and the American Red Cross to the FDA regarding reducing the risk of HIV transmission through cellular and tissue-based products express support for their new risk-based policies and updated guidance format. They also seek clarification on the timeframe for assessing risk in sexual partners, alignment of donor recommendations between blood and cellular products, and request an extended implementation period for necessary changes. The organizations aim to ensure safety, availability, and effectiveness of transfusion medicine and biotherapies.
Posted in Letters and Comments