Navigation Links
FDLI Publishes Comprehensive Handbook on Pharmaceutical Risk Management
Date:5/28/2008

300-Page Book, with Foreword by FDA's Janet Woodcock, MD, Provides Practical Guidance on New REMS Requirements

WASHINGTON, May 28 /PRNewswire-USNewswire/ -- Now that the Food and Drug Administration (FDA) has new authority to improve the safe use of pharmaceuticals, drug manufacturers can be required to develop comprehensive risk assessment evaluations and restrict their marketing on existing pharmaceuticals.

To help pharmaceutical companies, consultants and other drug industry stakeholders prepare and comply with the new rules on risk evaluation and mitigation strategy (REMS) mandated under the Food and Drug Administrations Act Amendments of 2007, FDLI has issued the most complete handbook on risk evaluation and management published to date: Pharmaceutical Risk Management: Practical Applications.

This comprehensive, 300-page book, which includes a foreword by Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research at FDA, provides practical guidance to enable drug companies to effectively negotiate the REMS pre- and post-marketing surveillance maze, including:

-- What actions to take to determine if the benefits of a drug outweigh its

risks; and

-- What to do if FDA decides new safety information requires companies to

make changes in the marketing of existing drugs.

The nuts-and-bolts book also includes instructive chapters on:

-- The environmental and historical context for risk management;

-- Proven strategies for designing and measuring REMS effectiveness;

-- Practical examples and case studies of successful risk management

strategies; and

-- Crisis management considerations.

The book also contains invaluable appendices, including FDA's guidance for industry on pre-marketing risk assessment.

"Knowing how to design, execute and evaluate a risk management and communications program can spell the difference between drug approval and approval delay," says co-editor Wayne L. Pines, President, Regulatory Services and Healthcare, APCO Worldwide, and former Associate Commissioner at FDA. The other two editors of the book are Jeffrey E. Fetterman, president and CEO of ParagonRx, a healthcare consulting firm, and Gary H. Slatko, M.D., the firm's Chief Medical Officer.

For more information on the book, Pharmaceutical Risk Management: Practical Applications, visit http://www.fdli.org or call (202) 371-1420.

Founded in 1949, FDLI publishes the award-winning, peer-reviewed Food and Drug Law Journal; the bimonthly magazine Update; FDA Directory; and dozens of books and publications for attorneys, regulatory affairs practitioners, scientists, health care professionals, government employees and marketers in the food and drug field.


'/>"/>
SOURCE Food and Drug Law Institute
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Harvard Business School Publishes a Case Study on Robert Wessman and Actavis
2. Lombardi Comprehensive Cancer Center publishes manual for childhood cancer survivors
3. The Lancet publishes first clinical trial data of a fully bioabsorbable drug-eluting stent
4. Stabilix Publishes Version 2 of Health Companion, a Personal Healthcare Management Tool
5. McGraw-Hill Higher Education Publishes Text on Innovative Electronic Health Records System
6. VWR International Publishes New Laboratory Casework and Technical Furniture Catalog
7. USP publishes Spanish edition of United States Pharmacopeia and National Formulary
8. USP Publishes Spanish Edition of United States Pharmacopeia and National Formulary
9. The Diabetes Educator publishes systematic reviews for diabetes management
10. Springer publishes La Chirurgia degli Organi de Movimento
11. The Endocrine Society Publishes White Paper Calling for Greater Minority Participation in Clinical Research
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , ... June 24, 2016 , ... Global law firm ... 2016 Legal Elite. The attorneys chosen by their peers for this recognition are considered ... Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal Elite ...
(Date:6/24/2016)... Plano, TX (PRWEB) , ... June 24, 2016 , ... ... taking part in Genome magazine’s Code Talker Award, an essay contest in which patients ... for an award to be presented at the 2016 National Society of Genetic Counselors ...
(Date:6/24/2016)... ... June 24, 2016 , ... Strategic Capital Partners, ... economy by obtaining investment capital for emerging technology companies. SCP has delivered ... already resulted in more than a million dollars of capital investment for five ...
(Date:6/24/2016)... ... June 24, 2016 , ... Advanced Plastic Surgery Institute ... pageant as its official Medspa Sponsor. Dr. Josh Olson, a board-certified plastic surgeon, ... , Dr. Olson says the decision to support the pageant in an official ...
(Date:6/24/2016)... ... 24, 2016 , ... Today, InhaleLabs.com (Inhale) offilially launched its site, ... matching users with high quality water pipes within an ideal price range. The site ... was founded by two brothers, Nick and Mike Hunter, who use medical cannabis to ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Ill. and INDIANAPOLIS , ... students receiving a Lilly Diabetes Tomorrow,s Leaders Scholarship is ... 2016 scholarship winners, announced today online at www.diabetesscholars.org ... let type 1 diabetes stand in the way of ... has supported the Foundation,s scholarship program since 2012, and ...
(Date:6/23/2016)... -- The vast majority of dialysis patients currently receive ... usually 3 times a week, with treatment times averaging ... equipment preparation and wait time.  This regimen can be ... who are elderly and frail.  Many elderly dialysis patients ... for some duration of time. Residents in ...
(Date:6/23/2016)... WASHINGTON , June 23, 2016  The ... Pharmaceuticals has joined the health policy research organization ... Steven Romano , MD, senior vice president and ... his company,s representative on the NPC Board of ... are pleased that Mallinckrodt has joined us in ...
Breaking Medicine Technology: