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Emmaus Receives NAI Classification from FDA

The inspection by two FDA Consumer Safety Officers found no objectional condition or practice in the six years that Endari has been marketed.

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By: Charlie Sternberg

Associate Editor

Emmaus Life Sciences Inc., a commercial-stage biopharmaceutical company, has received the “No Action Indicated” classification following a routine inspection by the United States Food and Drug Administration (FDA) of Emmaus’ Postmarketing Adverse Drug Experience (PADE) compliance program. The PADE program aims to shield patients from poor quality, unsafe, and ineffective dugs through proactive compliance strategies and risk-based enforcement actions.  A major objective of t...

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