FDA Proposes Codifying “Longstanding View” of CBE Supplements

January 16, 2008
FDA has just proposed amendments to the regulations governing a drug, biologic, or medical device manufacturers’ ability to implement labeling changes in advance of agency review and approval. The purpose of these amendments, proposed on January 15, 2008, is not to alter the requirements for CBE supplements but instead to codify the Agency’s longstanding position and practice regarding them. This proposed codification and the Agency’s accompanying summary may hold significant value for manufacturers throughout the litigation process.