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Legal Update

Proposed Rule Amending Regulations Governing Supplemental Applications Proposing Labeling Changes For Approved Drugs, Biologics, and Medical Devices

18 January 2008
Mayer Brown Legal Update
The FDA has proposed important new regulatory amendments to reaffirm existing law relating to when sponsors of new drugs, biologics, and medical devices may employ the "changes being effected" ("CBE") supplement process to change the labels on their products without FDA pre-approval.

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