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  • Regulatory NewsRegulatory News

    FDA Initiative to Re-Label Older Drugs Hits Significant Setback: Sources

    A multi-year, $26 million program launched last year by the US Food and Drug Administration (FDA) is now being partially shelved after running into significant difficulties, FDA sources tell Focus . Background The program, known as the Prescription Drug Labeling Improvement and Enhancement Initiative (PDLIEI or PDLI-EI) began in February 2013 when FDA announced its creation in the Federal Register and solicited public feedback on its goals. Simply put, the program i...
  • FDA Moves Forward With Drug Labeling Revision Project

    The US Food and Drug Administration (FDA) is out with new information about an initiative first announced in 2013 that is meant to convert the labeling of hundreds of older drugs into a newer and consumer-friendly format. Background In 2006, FDA passed the Physician Labeling Rule (PLR), a labeling format intended to make it easier for physicians and patients to understand some of the most important benefits and risks of a drug. For example, labeling highlights under...