FDA Releases Draft Guidance Updating Warnings for Labeling of Albumin, Highlighting Risk of Creutzfeldt Jakob Disease
On June 11, 2012, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled Draft Guidance for Industry: Amendment to ‘Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products.’ Found here, the Document highlights the recommended changes to labeling in light of current scientific knowledge. Creutzfeldt-Jakob Disease (“CJD”) is a debilitating brain disorder that results in rapidly declining neurological functioning and ultimately death. Related to bovine spongiform encephalitis (“BSE” or “Mad Cow Disease”), variant Creutzfeldt-Jakob Disease (“vCJD”) is extremely rare and thought…