Navigation Links
Risk Evaluation and Mitigation Strategy Experts Interpret New FDA REMS Guidance

WILMINGTON, Del., Oct. 1 /PRNewswire/ -- Yesterday, the FDA issued very important draft guidance for pharmaceutical and biotechnology companies for formatting, assessing and modifying Risk Evaluation & Mitigation Strategies (REMS) to ensure the safe use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

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

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:
(Date:6/23/2016)... , June 23, 2016 , ... on Thursday, July 7, 2016 , , , , LOCATION: ... , , , , EXPERT PANELISTS:  , , , ... Senior Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and ... The global pharmaceutical industry is witnessing an exceptional era. ...
(Date:6/23/2016)... and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of Astellas Farma ... as the company,s second affiliate in Latin America . ... ... Astellas Farma Colombia ... ...
(Date:6/23/2016)... 23, 2016  Guerbet announced today that it has ... Horizon Award . One of 12 suppliers ... for its support of Premier members through exceptional local ... and commitment to lower costs. ... of our outstanding customer service from Premier," says ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... TherapySites, ... its affiliation with Tennessee Counseling Association. This new relationship allows TherapySites ... Tennessee Counseling Association, adding exclusive benefits and promotional offers. , "TCA is extremely ...
(Date:6/26/2016)... , ... June 27, 2016 , ... Quality metrics are ... in many ways they remain in the eye of the beholder, according to experts ... publication of The American Journal of Managed Care. For the full issue, click ...
(Date:6/26/2016)... ... , ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop a ... fitness app plans to fix the two major problems leading the fitness industry today:, ... type program , They don’t eliminate all the reasons people quit their exercise ...
(Date:6/25/2016)... ... ... closing of Bruton Memorial Library on June 21 due to a possible lice infestation, as ... of head lice: the parasite’s ability to live away from a human host, and to ... one in the event that lice have simply gotten out of control. , As lice ...
(Date:6/25/2016)... Oklahoma (PRWEB) , ... June 25, 2016 , ... ... both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures ... Oklahoma City area —Johnson is one of the first doctors to perform the ...
Breaking Medicine News(10 mins):