Together with the FDA and other professional organizations, AABB is planning a workshop on cord blood licensure on March 8-10, 2010. This event will feature a two-day workshop and will provide an opportunity to understand the FDA requirements for cord blood licensure. Speakers will include FDA representatives and industry leaders. Included in registration, a third day is set aside for round table discussions on BLA submission preparations. This interactive session will give cord blood banks the opportunity to identify potential areas of collaboration and sharpen action plans. No FDA speakers will be present on the third day. Meeting information and registration.

Circular of Information for the Use of Cellular Therapy Products

The  Circular of Information (Circular) for the Use of Cellular Therapy Products  is intended to be an extension of the cellular product label. As an extension of container labels, each processing/issuing facility has the option and is encouraged to provide more facility or product specific information in the space provided in the Circular. The organizations involved in writing the Circular limited the scope to minimally manipulated cellular products such as peripheral blood progenitor cells, bone marrow, cord blood and leukocytes. The group recognizes the fact that there are other cellular products which could not be adequately covered in the Circular. The electronic version of the Circular has been enhanced to allow for addition of facility specific information at the end of the document.  

 FACT Clarifies Requirements for Reagents

The Cellular Therapy Standards require that reagents that come into contact with cellular therapy products during processing, storage, and/or administration be of the appropriate grade for the intended use. However, Processing Facility Quality Management Programs are required to qualify reagents not of the appropriate grade for the intended use. The criteria for appropriate qualifications of these reagents is described in the newly-released update of the fourth edition  Cellular Therapy Accreditation Manual  to more clearly explain the intent of Standards.  Read entire article.

FACT Welcomes New Board Members

The FACT Board of Directors recently welcomed several new members in 2010. The new Board members include representatives from FACT’s parent organizations, the American Society of Blood and Marrow Transplantation (ASBMT) and the International Society for Cellular Therapy (ISCT). They will be officially installed on the FACT Board of Directors during its meeting on February 23, 2010. All of the Board members are strong contributors to FACT, and have first-hand experience and understanding of the roles of the FACT constituency as inspectors and personnel of accredited organizations. The entire FACT community can look forward to continued leadership and support from the FACT Board of Directors in 2010.

FACT Announces Fourth Quarter Accreditations

One new blood and marrow transplant program earned accreditation and thirteen additional facilities received accreditation renewal during the fourth quarter of 2009. See the list of recently accredited facilities.