REGULATORY UPDATE: FDA Updates April 2020 CJD Guidance

August 28, 2020

FDA issued an updated Creutzfeldt-Jakob Disease (CJD) and variant CJD guidance to revise the terminology used to describe prion diseases in the April 2020 guidance of the same name. The agency removed the term “genetic forms of CJD” and replaced it with “familial prion diseases.” FDA also revised the background and discussion sections to update information on the National Hormone and Pituitary Program in the United States. In addition, the recommendation to permanently defer individuals who have received cadaveric pituitary human growth hormone was clarified in section IV. and the appendix.

No additional changes were made to the recommendations. AABB has prepared a table comparing the changes between the August and April guidance documents. Contact regualtory@aabb.org with questions.