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:3/27/2017)... ... March 27, 2017 , ... M&S Technologies, ... of Conformity for the Smart System® 20/20. CE Certification builds upon M&S's long-standing ... and specifications such as ANSI, ISO and proven test methods used in the ...
(Date:3/27/2017)... , ... March 27, 2017 , ... ... comprehensive weight management program at Women’s Excellence will help patients lose weight and ... physical exam. The specialists at Women's Excellence will measure BMI, body fat ...
(Date:3/27/2017)... ... 27, 2017 , ... The Association of Healthcare and Value ... their first Northeast Regional AHVAP Meeting. For 2017, Dr. Hayes will provide the ... value analysis professionals have a ‘seat at the table’ with clinical committees when ...
(Date:3/27/2017)... ... March 27, 2017 , ... Sodium determination ... are complicated and require expert user knowledge. In a live webinar on April ... the simplified, yet highly accurate, determination of sodium. , It has long been ...
(Date:3/27/2017)... ... March 27, 2017 , ... ... with opioids alone responsible for over 33,000 of the 52,404 drug-related deaths in ... Bill (AB) 1512, which proposes a tax on prescription opioids to fund drug ...
Breaking Medicine News(10 mins):
(Date:3/24/2017)... -- New England Pediatric Device Consortium (NEPDC) announced Velano ... and in-kind service towards the commercialization of the company,s ... blood draws less traumatic for children could go a ... We,re looking forward to working with Velano Vascular to ... the kids we treat," said Ann-Christine Duhaime , ...
(Date:3/24/2017)... 2017 Research and Markets has announced ... Consumer Strategies" report to their offering. ... Pain Management in ... treat their physical pain, emphasizing consumer survey analysis, including trends ... and adults who have selected illnesses/conditions strongly associated with physical ...
(Date:3/24/2017)... 24, 2017 ShangPharma, a leading ... cost-effective drug development and discovery services, technology, ... industry, announced today the intent for a ... be consolidating the Contract Research Organizations (CRO) ... ChemPartner. These entities include ChemPartner Shanghai, ChemPartner ...
Breaking Medicine Technology: