Media / News Releases
Aug 06, 2018
Electronic Submissions to the U.S. FDA – The Time Has Arrived!
As of May 2018 the U.S. FDA requires all submissions related to regulated medical products to be made electronically through the FDA’s Electronic Submissions Gateway (ESG).
Apr 01, 2018
Primary Endpoint Successfully Achieved in a Phase 2b/3 Study for Treatment of HIV-1 Subjects
Amarex Clinical Research helped a client successfully meet their primary endpoint in a Phase 2b/3 clinical trial of treatment-experienced HIV-1 patients.
Jan 29, 2018
Grand Opening Celebration of Amarex Taiwan, LLC
Global Biotechnology Monthly recently interviewed Dr. Kazem Kazempour, President & CEO of Amarex Clinical Research, about the US FDA’s continued support for the development and marketing of digital health application products.
Jan 18, 2018
Collaboration Between Hanbat National University, Republic of Korea and Amarex Clinical Research
On September 8, 2018, Amarex’s President & CEO, Dr. Kazem Kazempour, keynoted at the Trans 2018 digital health conference in Taipei, Taiwan.
Dec 20, 2017
Amarex Clinical Research Successfully Supports a 510(k) Approval in a Gastroenterology / Urology Indication
Amarex Clinical Research is pleased to announce that one of its clients has received a 510(k) approval from the U.S. FDA on a medical device for use in a Gastroenterology/Urology indication. Amarex supported the regulatory efforts of this submission, along with providing full trial services for a companion study.
Dec 13, 2017
Amarex Clinical Research passes GCP Audit conducted by the FDA
Amarex recently submitted an initial Pediatric Study Plan (iPSP) waiver request to the US FDA for a client’s product that is fast approaching the submission of an NDA. Amarex’s request for waiver was approved by the US FDA.
Nov 21, 2017
Amarex Clinical Research is Featured in a Montgomery College Economic Impact Video
Amarex is pleased to have been asked to be featured in Montgomery College’s - Economic Impact Video. This is an effort to provide more insight to the college and businesses of Montgomery County in Maryland.
Oct 23, 2017
Amarex Clinical Research to Attend BIO Europe in Berlin
Amarex will be attending the BIO Europe conference in Berlin over November 6-8. In order to further expand both its clinical trial services in Europe, and its customer base in Europe, Amarex will be attending this conference for the first time.