FDA Proposes Reclassification of Cyclosporine and Tacrolimus Assays

Summary

The FDA is proposing to reclassify cyclosporine and tacrolimus assays from class III to class II, allowing for greater regulatory oversight, following petitions from Dade Behring, Inc. and Microgenics, Inc., and aligning with the Federal Food, Drug, and Cosmetic Act and other relevant amendments.