Emmaus Life Sciences Ensures Drug Safety with FDA's Approval

Emmaus Life Sciences Inc., a biopharmaceutical company in its commercial stage, recently underwent a routine inspection by the FDA concerning its Postmarketing Adverse Drug Experience (PADE) compliance program. The inspection, conducted over two and a half days by two FDA Consumer Safety Officers, resulted in a "No Action Indicated" classification.

The PADE program is designed to ensure that patients are protected from substandard, unsafe, and ineffective drugs through proactive compliance measures and risk-based enforcement. Its primary goal is to guarantee the accurate, reliable, and timely submission of safety data to the FDA in accordance with postmarketing regulations.

According to Charles Stark, Pharm.D., Chief Scientific Officer of Emmaus Life Sciences, this favorable inspection outcome places Emmaus among the top 16% of all companies inspected in 2019 based on FDA inspection results. He emphasized Emmaus' commitment to providing high-quality Endari (L-glutamine oral powder) and monitoring its safety for patients with Sickle Cell Disease. Stark credited Emmaus' adherence to FDA regulations, particularly in surveillance, data receipt, evaluation, and timely reporting, along with the support of their pharmacovigilance partner, APCER Life Sciences, for these achievements.