FDA's CBE Codification Could Help Defendants

Law360, New York (January 17, 2008, 12:00 AM EST) -- FDA has just proposed amendments to the regulations governing a drug, biologic, or medical device manufacturer's ability to implement labeling changes in advance of agency review and approval. See Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices (“CBE Amendment”), 73 Fed. Reg. 2848 (Jan. 16, 2008) (to be codified at 21 CFR Parts 314, 601, and 814).

The purpose of these amendments, proposed on Jan. 15, 2008, is not to alter the requirements for CBE supplements but instead to codify the Agency’s...
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