When to Change Prescription Drug Labeling

When to Change Prescription Drug Labeling?

You don’t have to be a prescription drug labeling consultant to realize that a case series of serious events in the literature, FDA safety alert, FDA labeling change notification letter, or other new safety information should prompt a review of drug product labeling (aka package insert). That is not what this paper is about. This…

Investigational New Drug Application (IND)/Special Protocol Assessment (SPA)

FDA Delays Publication of Generic Drug CBE Rule Until Fall 2015

In a move that was not entirely unexpected, FDA delayed publication of a rule proposed last year that would allow generic drug sponsors to update safety warnings using the changes being effected (CBE) process. While the comment period had earlier been extended, there was no corresponding extension in the scheduled publication date of December 2014.…

RAPS Reports Generic Drug Industry Threatens FDA With Lawsuit Over Drug Labeling Proposal

PDG™ is a pharmaceutical consultant serving drug sponsors around the world. On July 28, 2014, PDG™ published a chronology of events related to FDA’s proposed rule that would allow generics to use the CBE process to update their labeling with new safety information. Subsequently, RAPS Regulatory Focus (Alexander Gaffney, RAC, October 7, 2014) reported that…

Generic Pharmacovigilance/Safety Surveillance and CBEs

Generic Pharmacovigilance/Safety Surveillance & CBEs

As pharmaceutical consultants, PDG devotes considerable resources to both brand & generic drug safety surveillance and labeling issues.  As such, we have followed with great interest the proposed rule entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.”  For ease of reference, we’re going to begin to refer to it as the…