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WILMINGTON, Del., Oct. 1 /PRNewswire/ -- Yesterday, the FDA issued very important draft guidance for pharmaceutical and biotechnology companies for formatting, assessing and modifying Risk Evaluation & Mitigation Strategies (REMS) to ensure the safe use of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:9/18/2017)... , Sept. 18, 2017 EpiVax, ... of bioinformatics and immune engineering, today announced ... influenza A (H7N9) vaccine. ... to seasonal influenza and presents a challenge ... prior exposure to be effective. Using state-of-the-art ...
(Date:9/12/2017)... SAN FRANCISCO , Sept. 12, 2017 /PRNewswire/ ... Lifecycle Management Solutions (VLMS), is pleased to announce ... as a member of its Board of Directors ... 2017. ValGenesis VLMS enables life science companies to ... eliminate the use of paper in this process. ...
(Date:9/7/2017)... , Sept. 7, 2017  Eli Lilly and ... actions to streamline operations to more efficiently focus ... its cost structure. Global workforce reductions, including those ... expected to impact approximately 3,500 positions. ... expects annualized savings of approximately $500 million that ...
Breaking Medicine Technology:
(Date:9/19/2017)... ... , ... Trusted debt-reduction firm CreditAssociates, LLC has announced two important milestones. To ... $835 million in resolved debt for its clients. , Credit card debt, unpaid hospital ... of debt settled by the company. With more than a decade of combined service ...
(Date:9/19/2017)... ... September 19, 2017 , ... ... winners of the Entrepreneur Innovation Awards (EIA), held this past Thursday night at ... Connecticut-based companies and entrepreneurs, presented their innovative project ideas to a panel of ...
(Date:9/19/2017)... ... September 19, 2017 , ... ... of Professional Benefit Administrators (SPBA) hosted “Expanding Your Success” with an educational ... as it focused on best practices for third party administrators (TPAs) related to ...
(Date:9/19/2017)... ... ... The Semper Fi Fund, one of the nation’s highest-rated veteran nonprofits serving ... and a compelling documentary that provide unique insights and powerful advice to help address ... ongoing mission. , Each of the videos focuses on a specific issue that’s highly ...
(Date:9/19/2017)... Toronto, Ontario (PRWEB) , ... September 19, 2017 , ... ... governmental regulation of pollutants have fallen on deaf ears, leaving the water industry itself ... one company that stays ahead of the curve in the field of natural ...
Breaking Medicine News(10 mins):