CBER Expands Its 2017 Guidance Agenda

CBER added several topics to its guidance agenda for 2017 in its mid-year update, including blood donor requalification and the use of certain serum tests in reducing infection transmission.

The center plans to issue new guidance this calendar year on an acceptable Circular of Information for the Use of Human Blood and Blood Components — a document prepared jointly by the AABB blood standards group, the American Red Cross, America’s Blood Centers, and the Armed Services Blood Program.

CBER also plans to update a 2010 guidance on nucleic acid testing for HIV-1 and Hepatitis C.