Generic drug manufacturers could face new regulatory requirements from FDA

FDA recently announced critically important information for all generic drug manufacturers which will require generic drug manufacturers to develop and implement safety-related changes to their labeling.

If/when implemented, generic companies will have a paradigmatic shift in their role related to safety surveillance and labeling updates. Prior to this new rule generic companies could only change their labeling when instructed to do so by the FDA, or when the brand name manufacturer changed the labeling of the reference listed drug.

PDG has over fifty years of collective experience with pharmaceutical labeling of NDAs and ANDAs.  This includes the collection and evaluation of postmarking adverse events, the preparation of updated product labeling, and the dissemination of accurate, complete and timely product related information to health-care providers, patients and consumers. PDG has the necessary experience and expertise to assist generic manufacturers in this new era of labeling opportunities and responsibilities.

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