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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...