U.S. FDA Grants Fast Track Designation to Amarex Client PRG S&T Inc.
Germantown, MD, USA (October 22, 2020) – Amarex Clinical Research, LLC, an NSF International company announced that the U.S. FDA granted Fast Track designation to Amarex’s client PRG S&T Inc. for PRG’s drug Progerinin, being tested as a treatment for Hutchinson-Gilford Progeria Syndrome (HGPS) and Werner Syndrome (WS). The Phase I study will be conducted in healthy subjects.
Dr. Kazem Kazempour, President & CEO of Amarex, stated, “The U.S. FDA Fast Track program provides extra assistance from the FDA to support INDs for rare, serious diseases. We were very pleased the FDA awarded this special and valuable designation for PRG’s development program. HGPS and WS are both debilitating diseases with almost no drug treatments. We are also proud to have been selected by PRG to provide full clinical trial services for the pending study, assisting in bringing this important drug to market”.
The FDA Fast Track designation (FTD) is an approval process designed to facilitate the development, and expedite the review, of drugs that treat serious conditions and fill a current unmet medical need. The intent of this program is to get important new drugs to the patient earlier.
About Amarex Clinical Research, LLC, an NSF International company
Amarex Clinical Research, LLC, an NSF International company, is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research. Their combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides services in Project Management: Phase I-IV, BE/BA, PK/PD; Regulatory Affairs: FDA Applications and meetings, applications to International Health Authorities, GxP Compliance Audits; Clinical Operations; Adaptive Study Designs; Statistical Analysis; Data Management; Medical Monitoring; Safety and Pharmacovigilance; and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products assisted by quality, cost-efficient services. For more information visit www.amarexus.com.
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