Navigation Links
ParagonRx Files with FDA REMS Panel Interim Analysis for Opioid Drugs Study

WILMINGTON, Del., July 15 /PRNewswire/ -- ParagonRx, a healthcare consulting leader in risk management and the appropriate use of drugs, has filed its interim analysis of a study that shows how its proprietary approach to risk management can help manufacturers of opioid drugs meet FDA standards for risk evaluation and mitigation strategy (REMS.) ParagonRx had presented abbreviated study results to the FDA during public hearings earlier this year.

The interim analysis can be accessed at ParagonRx's website,

"ParagonRx has developed a proprietary approach to risk management using an adaptation of failure modes and effect analysis called RxFMEA(R)," says Jeffrey Fetterman, President and CEO of ParagonRx, "and we are currently applying this approach to the medication use process for long-acting opioids. RxFMEA(R) provides a rigorous assessment to identify key causes of sub-optimal outcomes and to prioritize those behaviors that are the most important to address."

ParagonRx is a Delaware-based company that works with pharmaceutical, biotech and medical devices companies to design and implement REMS and other risk management plans as well as better market under-utilized drugs.

SOURCE ParagonRx
Copyright©2009 PR Newswire.
All rights reserved

Page: 1

Related biology technology :

1. ParagonRx Creates New Website Featuring REMS Help Center for Pharma
2. Microbix Files First Patent Applications On Novel Technology Platform For Large Semen Sexing Market
3. OncoGenex Pharmaceuticals Files Shelf Registration Statement
4. CEL-SCI Files Patent Application to Support Companys Treatment for More Virulent Strain of H1N1 Swine and Other Influenza Viruses
5. Pharmacyclics Files Registration Statement for Rights Offering
6. Onyx Pharmaceuticals Files Complaint Against Bayer Corporation
7. Poniard Pharmaceuticals Files Shelf Registration
8. Sinovac Biotech Ltd. Files Annual Report on Form 20-F
9. SPO Medical Files Annual Report for Fiscal 2008
10. Vermillion, Inc. Files a Voluntary Petition for Reorganization Relief Under Chapter 11 of the United States Bankruptcy Code
11. Shire Files Lawsuit Against Natco Pharma for Infringement of FOSRENOL(R) (lanthanum carbonate) Patents
Post Your Comments:
(Date:6/24/2016)... , June 24, 2016  Regular discussions on a ... take place between the two entities said Poloz. ... Ottawa , he pointed to the country,s ... the federal government. ... said, "Both institutions have common economic goals, why not sit ...
(Date:6/23/2016)... ... June 23, 2016 , ... ... of its second eBook, “Clinical Trials Patient Recruitment and Retention Tips.” Partnering with ... in this eBook by providing practical tips, tools, and strategies for clinical researchers. ...
(Date:6/23/2016)... -- A person commits a crime, and the detective uses ... criminal down. An outbreak of foodborne illness makes ... uses DNA evidence to track down the bacteria that caused ... not. The FDA has increasingly used a complex, cutting-edge technology ... Put as simply as possible, whole genome sequencing is a ...
(Date:6/23/2016)... , June, 23, 2016  The Biodesign Challenge (BDC), ... new ways to harness living systems and biotechnology, announced ... (MoMA) in New York City . ... participating students, showcased projects at MoMA,s Celeste Bartos Theater ... Antonelli , MoMA,s senior curator of architecture and design, ...
Breaking Biology Technology:
(Date:5/20/2016)... , May 20, 2016  VoiceIt is excited ... with VoicePass. By working together, VoiceIt ...  Because VoiceIt and VoicePass take slightly different approaches ... increases both security and usability. ... about this new partnership. "This marketing ...
(Date:4/28/2016)... and BANGALORE, India , April ... EdgeVerve Systems, a product subsidiary of Infosys (NYSE: ... today announced a global partnership that will provide ... to use mobile banking and payment services.      ... a key innovation area for financial services, but it also ...
(Date:4/15/2016)... CHICAGO , April 15, 2016  A ... companies make more accurate underwriting decisions in a ... offering timely, competitively priced and high-value life insurance ... health screenings. With Force Diagnostics, rapid ... and lifestyle data readings (blood pressure, weight, pulse, ...
Breaking Biology News(10 mins):