Will Generic Manufacturers Really be Required to Make CBE Label Changes?

We doubt it. However, after 6 years, FDA may be on the verge of finalizing the “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” rule. We called it the “Generic CBE rule” until 2014 when PhRMA and GPhA got together and proposed an alternative known as the Expedited Agency Review. That would make it the “EAR” rule. The bottom line is that, as proposed, the rule would require generics to make safety related labeling changes using the CBE process. The EAR would not. While the projected finalization date has rolled back multiple times, we cannot recall a time that the finalization date was still standing at this late stage. We’ll see – although we were reminded of the date in December 2016 Federal Register. Click here for a paper on the topic or here for a paper that contains a chronology of events that we have consistently updated as related events have unfolded.

If you’re planning ANDA development of a complex drug and need assistance, feel free to contact us. For that matter, if the rule is passed and raises questions in your organization, our labeling and pharmacovigilance experts are also here to help.