WILMINGTON, Del., July 13 /PRNewswire/ -- ParagonRx, a Delaware-based company which specializes in programs for the appropriate use of medications, has launched a new website - www.paragonrx.com - that includes a "REMS Hub" for pharmaceutical and biotech companies needing information and assistance in complying with new FDA requirements to ensure the medical benefits of a drug outweigh its risks and dangerous side effects.
"REMS, or Risk Evaluation and Mitigation Strategy, requires a whole new mindset for many professionals in the industry," according to ParagonRx CEO Jeffrey Fetterman, "in that patient safety is no longer merely a statistic that is passively measured for regulatory compliance. Now, patient safety is an objective that is actively managed by many functional groups and disciplines, including pharmacovigilance, marketing, medical, regulatory and legal. In many ways, risk management, including REMS, is becoming its own new discipline, and we believe that our online REMS Hub will be of great use to our colleagues in many disciplines.
"Our job is always to make our clients jobs easier," Fetterman continues. "The new website was specifically designed to make it simpler to share the new lessons being learned as we work through the evolving REMS processes. We all share an overwhelming desire to improve patient safety while ensuring the benefits of a pharmaceutical or biological solution can address a patient's health needs. Our goal is to use the website and Internet world to help build better communication and educational strategies reducing risks for physicians and patients."
The REMS Hub addresses the related but varying needs of pharma and bio companies working with risk management and REMS in any of a product's key stages - development, peri-approval, launch, and post-marketing. The Center also explains how a science-based approach to REMS development can assure both safer product use and often broader product use, as well.
(Note to media: Fetterman is available for interviews)
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