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 Drug Industry Threatens FDA With Lawsuit Over Drug Labeling Proposal”. The rule is currently scheduled to be finalized in December 2014. PDG™ will keep you posted. See our full posting at Generic Pharmacovigilance/Safety Surveillance & CBEs.
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