Pharmaceutical Development Group

Pharmaceutical Consultant and FDA Regulatory Strategist

Pharmaceutical Consulting and Generic Drug Professionals

Pharmaceutical Development Group

On November 13, 2013, FDA proposed a new rule known as the 'Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products'. We here at PDG dubbed it the 'Generic CBE Rule', because it would allow for generics to employ CBEs (or PAS) to effect safety labeling changes to which sameness regulations would not apply.

However, a year later, GPhA and PhRMA proposed an alternative known as the Expedited Agency Review (EAR). According to the proposal, an EAR would 'establish defined time parameters for FDA to take action on a label change made: 1) following FDA's receipt and review of 'new safety information'1) from an NDA/ANDA holder; or 2) following review of data received through the Sentinel System and/or other databases including global sources that are suggestive of a need for a label change.

The EAR process would replace the changes being effected process for safety-related labeling changes now permitted under 21 CFR §314.70(c)(6)(iii). The EAR would require FDA to provide NDA and ANDA holders with prompt notice of approval of a required label change, and it would specify the timeframes for NDA and ANDA holders to make a corresponding labeling change'.

The final rule is expected to be issued in July of this year.

Download to find out more.

Available Downloads