Media / News Releases

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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).

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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.

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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.

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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.

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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. 

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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.

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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.

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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.