Generic Drug Industry Threatens FDA With Lawsuit Over Drug Labeling Proposal
By Alexander Gaffney, RAC -
Published 07 October 2014
The generic pharmaceutical industry's most prominent trade body, the Generic Pharmaceutical Association (GPhA), is threatening to sue the US Food and Drug Administration (FDA) if the agency finalizes a change in its labeling regulations that would make it easier for generic drug companies to update their product's labels in response to adverse events.
Categories: News, US, CDER, Generic drugs, Prescription drugs, Labeling, Postmarket surveillance
Tags: Generic Drug Labeling, Generic Drug Labeling Rule, GPhA, Ralph Neas, Lawsuit