FDA EIR - Nexgen Pharma Inc - August 17, 2018

An FDA inspection of Nexgen Pharma, Inc. in Irvine, CA, was conducted from August 13-17, 2018, to assess its Postmarketing Adverse Drug Experience (PADE) reporting. This surveillance inspection, following Compliance Program 7353.001, identified four significant observations related to regulatory compliance.

Key issues included the lack of adequately developed written procedures for the surveillance, evaluation, and reporting of post-marketing adverse drug experiences. Specifically, the company lacked procedures for handling 15-day alert reports from scientific literature and for preparing and submitting Periodic Adverse Drug Experience Reports (PADERs). Nexgen Pharma also failed to submit required PADERs, instead incorrectly including safety information within Annual Reports. Additionally, several Annual Reports were not submitted within the mandated 60 days of the product's approval anniversary. Finally, not all individual case safety reports, particularly non-serious adverse drug experiences, were submitted electronically via the Safety Reporting Portal.

Management acknowledged these deficiencies and committed to revising standard operating procedures to rectify the procedural gaps and ensure correct submission of PADERs. They also stated their intent to improve the timeliness of annual report submissions and were advised by the FDA to retrospectively submit unfiled electronic individual case safety reports. Nexgen Pharma's management affirmed their commitment to achieving full compliance.