Navigation Links
Risk Evaluation and Mitigation Strategy Experts Interpret New FDA REMS Guidance
Date:10/1/2009

WILMINGTON, Del., Oct. 1 /PRNewswire/ -- Yesterday, the FDA issued very important draft guidance for pharmaceutical and biotechnology companies for formatting, assessing and modifying Risk Evaluation & Mitigation Strategies (REMS) to ensure the safe use of pharmaceutical products.

Jeffrey Fetterman and Dr. Gary Slatko, both principals of ParagonRx, have helped many companies prepare REMS and related safety plans. They have previously co-authored two books on the topic and are now reviewing and interpreting this draft FDA guidance in a series of blog articles published at http://blog.paragonrx.com/.

Both experts are available for interviews and speaking engagements on this topic. The experts can be accessed by calling Roger Morris or directly at 302-504-0400.

The new draft REMS guidance document and other REMS resources are also available at www.paragonrx.com.

SOURCE ParagonRx


'/>"/>
SOURCE ParagonRx
Copyright©2009 PR Newswire.
All rights reserved

Page: 1

Related medicine technology :

1. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
2. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
3. Nventa Evaluation Complete for First Three Cohorts in HspE7 Phase 1 Cervical Dysplasia Trial
4. Nventa Completes Safety Evaluation on Final Cohort in HspE7 Phase 1 Cervical Dysplasia Trial
5. Quantum Immunologics, Inc. and the South Alabama Medical Science Foundation Announce an Early Clinical Evaluation of a Novel Immuno-therapeutic Vaccine for Treating Advanced Human Breast Carcinomas
6. Champions Biotechnology and Concordia Pharmaceuticals Complete Service Agreement and Begin Preclinical Evaluation of Oncology Drugs
7. What is the Optimal Method of Ischemia Evaluation in WomeN: Preliminary Data from the WOMEN Study
8. Lotus Pharmaceuticals, Inc.s New Drug Laevo-Bambutero Begins Evaluation for Clinical Trials
9. Walter Reed Evaluation Concludes FirstVue(TM) HBSAG Test is Preferred over Other Rapid Tests
10. Cardium Completes Initial Patient Evaluation Period for MATRIX Phase 2b Excellarate Clinical Study
11. Arbios Provides Clinical Strategy for SEPET(TM) Pivotal Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016 ... appointment of Dr. Edward Futcher to ... Director, effective June 23, 2016.Dr. Futcher was also ... and Governance Committees.  As a non-executive member of ... expertise and strategic counsel to VolitionRx in connection ...
(Date:6/23/2016)... June 23, 2016 Research and ... Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), ... Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is projected ... CAGR of 6.1% in the forecast period 2016 to ...
(Date:6/23/2016)... 23, 2016 Research and Markets has ... 52" report to their offering. ... creates a favourable commercial environment for MedImmune to enter. The ... that will serve to drive considerable growth for effective anti-influenza ... to cap sales considerably, but development is still in its ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their media with ... X," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Color ... users can now reveal the media of their split screens with growing colorful ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... patient payment industry today announced its strategic partnership with Connance, a healthcare ... , The two companies’ proven, proprietary technology combine to provide health systems, ...
(Date:6/27/2016)... Park, KS (PRWEB) , ... June 27, 2016 , ... ... in retailers of Eyeglasses . , Millions of individuals in the United States ... eyeglasses have become a way to both correct vision and make a fashion statement. ...
(Date:6/26/2016)... Battle Creek, Michigan (PRWEB) , ... June 26, 2016 , ... ... abuse, joined as sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table ... held in honor of the city’s history as home to some of the world’s ...
(Date:6/26/2016)... ... ... PawPaws brand pet supplements owned by Whole Health Supply is ... of felines. The formula is all-natural and is made from Chinese herbs that have ... Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root Extract ...
Breaking Medicine News(10 mins):