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 the PADE program is to ensure that accurate, reliable, and timely safety data are submitted to the FDA in compliance with postmarking laws and regulations.

The two and a half-day inspection by two FDA Consumer Safety Officers found no objectional condition or practice in the six years that Endari has been marketed and thereby received a “No Action Indicated” (NAI) inspection classification.

“Based on the 2019 FDA inspection results survey, this places Emmaus within the top 16% of all companies investigated in 2019,” stated Charles Stark, Pharm.D., Chief Scientific Officer of Emmaus Life Sciences, Inc. “This exemplifies Emmaus’ mission to provide the highest quality Endari (L-glutamine oral powder) and monitor its safety for our patients living with Sickle Cell Disease. These outcomes were possible due to the consistent and dedicated compliance to FDA regulations around surveillance, receipt, evaluation, and timely reporting of safety data by the Safety and Regulatory colleagues at Emmaus (Rafael Razon, M.D. and Rajani Singh). In addition, Emmaus is grateful to APCER Life Sciences, our long-standing Pharmacovigilance business partner, for their continued support.”