Pharmaceutical Development Group

Pharmaceutical Consultants and Drug Development Strategists

Drug Monitoring and Safety: Always an Important Management Concern; Now More So

Pharmaceutical Development Group

Safety surveillance and pharmacovigilance consulting to generic drug manufacturers, as well as generic drug labeling consulting may soon become a service in demand.

In November 2013, FDA proposed a rule entitled 'Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products'. By March 2014, there were just over 60 comments to the docket and finalization of the rule was targeted for December 2014.

The muted response was surprising given that the proposed rule sought to allow generic manufacturers to employ the CBE for safety related labeling changes as well as temporary differences between generic and RLD labels. However, in November 2014, GPhA/PhRMA put forth a counter-proposal.

So much for a muted response. The comment period, originally closed in March 2014, was reopened in February 2015, and over 23,000 comments were then received.

The date for finalization has now been extended to July 2016. The GPhA/PhRMA counter-proposal is known as the 'Expedited Agency Review' (EAR) and, as proposed in 2014, seeks to do away with the CBE for safety related changes to labeling for both NDA and ANDA holders.

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