Skip to main content

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.
The Build a Report feature requires the use of cookies to function properly. Cookies are small text files that are placed on your computer by websites that you visit. They are widely used in order to make websites work, or work more efficiently. If you do not accept cookies, this function will not work. For more information please see our Privacy Policy

You have no pages selected. Please select pages to email then resubmit.