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WILMINGTON, Del., Oct. 1 /PRNewswire/ -- Yesterday, the FDA issued very important draft guidance for pharmaceutical and biotechnology companies for formatting, assessing and modifying Risk Evaluation & Mitigation Strategies (REMS) to ensure the safe use of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:6/2/2015)... Research and Markets ( http://www.researchandmarkets.com/research/zkkg9q/blood_processing ) has announced ... - Global Strategic Business Report" report to their offering. ... US, Canada , Japan ... , Latin America , and Rest of ... 2014 through 2020. Also, a seven-year historic analysis is provided ...
(Date:6/2/2015)... 02, 2015 Research and Markets ( http://www.researchandmarkets.com/research/sn8mlw/picture_archiving ) ... Communication Systems (PACS) - Global Strategic Business Report" report ... analytics for the US, Canada , ... Asia-Pacific , Latin America , ... are provided for the period 2014 through 2020. Also, a ...
(Date:6/2/2015)... , June 2, 2015 Today the ... over 150 major food companies, retailers, and human ... Forum on Antibiotic Stewardship. CSTE is committed to ... bacteria, detect resistant strains, preserve the efficacy of ... resistant infections. CSTE continues to serve ...
Breaking Medicine Technology:Blood Processing Supplies and Equipment Market - Global Strategic Business Report 2015-2020 2Blood Processing Supplies and Equipment Market - Global Strategic Business Report 2015-2020 3Picture Archiving and Communication Systems (PACS) - Global Strategic Business Report 2015: User Demand Favors Integrated RIS/PACS Solutions 2
... 2011 Results from a two-year retrospective cohort study ... Academy of Neurology (AAN), Hawaii, U.S., showed that patients ... including hypertension, cardiac dysrhythmias and chronic ischemic heart diseases ... controls without RLS. "These findings suggest ...
... Pharmaceuticals, Inc. (AMEX: AEN ), a developer ... announced today top-line results from its clinical study evaluating ... disease (AD) and mild cognitive impairment (MCI). The clinical ... and decreasing serum free copper. In addition, secondary outcomes ...
Cached Medicine Technology:New Research Links Restless Legs Syndrome (RLS) to Cardiovascular Disease 2New Research Links Restless Legs Syndrome (RLS) to Cardiovascular Disease 3Adeona's Clinical Study of reaZin™ Meets Primary Outcomes of Increasing Serum Zinc and Decreasing Serum Free Copper 2Adeona's Clinical Study of reaZin™ Meets Primary Outcomes of Increasing Serum Zinc and Decreasing Serum Free Copper 3Adeona's Clinical Study of reaZin™ Meets Primary Outcomes of Increasing Serum Zinc and Decreasing Serum Free Copper 4Adeona's Clinical Study of reaZin™ Meets Primary Outcomes of Increasing Serum Zinc and Decreasing Serum Free Copper 5Adeona's Clinical Study of reaZin™ Meets Primary Outcomes of Increasing Serum Zinc and Decreasing Serum Free Copper 6Adeona's Clinical Study of reaZin™ Meets Primary Outcomes of Increasing Serum Zinc and Decreasing Serum Free Copper 7
(Date:6/2/2015)... 2015 Residents looking for a new ... a more convenient location now that Coast Dental Kissimmee ... 2310 E. Irlo Bronson Memorial Highway, Suite C-106, Kissimmee, ... a mile away from its original location, and features ... patient areas with digital intraoral and panoramic x-ray system ...
(Date:6/2/2015)... New Jersey (PRWEB) June 02, 2015 ... (Horizon BCBSNJ) announced today that its Walking and Wellness ... Classic Presented by Acer, has raised another $3,000 for ... Natalie Gulbis undertook the challenge, recording 32,000 steps on ... at Stockton Seaview Hotel & Golf Club in Galloway ...
(Date:6/2/2015)... Did you wish Ryder Weise a happy sixth ... family isn’t asking for presents, but instead a donation to ... Cure HHT DC Walk. , Ryder was diagnosed with HHT ... vessels leading to sudden and extreme bleeding throughout the body. ... 3 years old in the form of daily nosebleeds, fatigue ...
(Date:6/2/2015)... June 02, 2015 Erbelli’s Gourmet Pizzeria, ... to promote its handmade gourmet pizzas and calzones, fresh ... the website is new, the recipes are not—they have ... The main feature of the site is the menu, ... and descriptions of all the items. You can order ...
(Date:6/2/2015)... 2015 MAP Health Management, LLC, a ... management for addiction treatment facilities, announced today that Jared ... Marketing. Mr. Smith will be responsible for developing and ... visibility of MAP’s core message, products and initiatives. , ... Manager at Cottonwood Financial in Irving, Texas, where he ...
Breaking Medicine News(10 mins):Health News:Coast Dental Office Opening In Kissimmee with Expanded Technology 2Health News:LPGA’s Natalie Gulbis Raises an Additional $3,000 for the Boys & Girls Club of Atlantic City Through Horizon BCBSNJ’s Walking and Wellness Challenge 2Health News:Six-Year-Old Walks to Bring Awareness to Genetic Disease 2Health News:Erbelli’s of Bradenton Launches New Mobile-Friendly Website 2Health News:Jared Smith Joins MAP Health Management, LLC, as Vice President of Marketing 2
... of practice, which all UK doctors must observe, the doctors ... ,The ethics and code of the Congregation for the ... Catholic hospital cannot refer people for abortions - they can't ... just round the corner. ,With these codes as a ...
... a new tension has sprung after a large number ... by Gilde of Norway//, under the brands Gilde Birkebeiner ... , The Norwegians authorities have advertised throughtout the country ... ground beef. Food authorities say that they suspect ...
... especially teenagers who sport T-shirts, hats and other wares that ... more likely to get inspired to initiate early with the ... items in their closet. This is a study conducted by ... the American Journal of Preventive Medicine. ,Dr. Auden ...
... in rough weather, reveals the resistance to a badly ... was revealed by a leading expert on prisons and ... took on this incendiary issue when his political capital ... of reform is a huge blow," said Haney professor ...
... at the Ohio State University have discovered a hitherto unknown ... HIV/AIDS virus. //It was found that two proteins that help ... of the HIV virus, which is vital for its survival ... in the Proceedings of the National Academy of Sciences says ...
... School of Public Health in Boston, heart disease in women ... weight control. ,The study was based on a ... (BMI) taken regularly. They were also routinely questioned about their ... ,Women with a BMI between 18.5 and 24.9 had the ...
Cached Medicine News:Health News:Catholic Church and Abortion. 2Health News:An urgent need for prison reforms: California! 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: