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

Labeling / Marketing, Pharmaceutical Consulting News, Quality Assurance & Compliance, Regulatory Updates, Safety & Pharmacovigilance, Submissions

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

Labeling / Marketing, Pharmaceutical Consulting News, Quality Assurance & Compliance, Regulatory Affairs, Regulatory Updates, Safety & Pharmacovigilance, Submissions

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…