Emmaus Life Sciences reports compliance with FDA postmarketing safety regulations for Endari, its sickle cell disease treatment. After a 2.5-day inspection under the FDA’s Postmarketing Adverse Drug Experience (PADE) program, no issues were detected in the US for six years Endari has been marketed, showing Emmaus’ commitment to patient safety and adherence to requirements. The inspection resulted in this drug’s “No Action Indicated” classification. Charles Stark‘ chief scientific officer, emphasized the company’s dedication to providing high-quality treatment while closely monitoring its safety for SCD patients.
At OxyDial, we are excited at Emmaus’ commitment to patient safety and treatment efficiency. It’s encouraging to see companies prioritizing postmarketing surveillance and maintaining high pharmaceutical standards.
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