Navigation Links
ParagonRx Files with FDA REMS Panel Interim Analysis for Opioid Drugs Study
Date:7/15/2009

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, www.paragonrx.com/experience/comments-to-the-fda/

"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:
*Name:
*Comment:
*Email:
(Date:9/13/2017)... (PRWEB) , ... September 13, 2017 , ... ... with the life sciences industry to improve patient outcomes and quality of life ... & impurities, has been named a US expert to the International Standards ...
(Date:9/12/2017)... ... September 12, 2017 , ... ... growing b2b product testing and development companies will be exhibiting at the 16th ... , Contract Pharma is an educational conference for pharma and ...
(Date:9/12/2017)... ... September 12, 2017 , ... Soybean researchers ... to submit a "pre-proposal” by October 15, prior to completing a full grant ... are aligned with our priorities, and to encourage researchers to further develop ones ...
(Date:9/12/2017)... ... ... Facet Life Sciences, a leading provider of development solutions (software and services) ... joined the company’s Board of Directors. , Dr. Massa brings 38 years of ... he served as VP and Head of Global Regulatory Operations at Sanofi. During his ...
Breaking Biology Technology:
(Date:3/30/2017)... March 30, 2017 Trends, opportunities and forecast ... behavioral), by technology (fingerprint, AFIS, iris recognition, facial recognition, ... others), by end use industry (government and law enforcement, ... and banking, and others), and by region ( ... Asia Pacific , and the Rest ...
(Date:3/24/2017)... , March 24, 2017 The Controller General ... Controller Mr. Abdulla Algeen have received the prestigious international IAIR ... Continue Reading ... ... picture) and Deputy Controller Abdulla Algeen (small picture on the right) have ...
(Date:3/22/2017)...   Neurotechnology , a provider of high-precision ... the release of the SentiVeillance 6.0 ... recognition using up to 10 surveillance, security and ... new version uses deep neural-network-based facial detection and ... a Graphing Processing Unit (GPU) for enhanced speed. ...
Breaking Biology News(10 mins):