ParagonRx Creates New Website Featuring REMS Help Center for Pharma

Mon Jul 13, 2009 2:30pm EDT
 
[-] Text [+]
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)


SOURCE  ParagonRx

Roger Morris for ParagonRx, +1-610-274-8027, londonbritain@msn.com

 

Featured Broker sponsored link

Editor's Choice

A selection of our best photos from the past 24 hours.   Slideshow 

Most Popular on Reuters

  • Articles
  • Video