Proposed CBE Rule Could Increase Generic Liability
By Mari Serebrov
Monday, July 8, 2013
The FDA is working on revisions to its labeling regulations that could revoke the free pass the Supreme Court has handed generic drugmakers when it comes to state failure-to-warn claims. The proposed changes would put generic drugmakers on par with brand drugmakers in the submission of changes-being-effected (CBE) labeling supplements.
Outside of the US
Part of Thomson Reuters
Note: our contact information has changed
In the U.S. and Canada: +1-800-336-4474
Outside the U.S.: +44-203-684-1796
Hours: Monday - Friday, 8:00am - 6:00 pm EST
© 2017 Thomson Reuters. Reproduction, reposting content is strictly prohibited.