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:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding ... of its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. ... James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the ... In terms of the latter, setting the bar too high can result in disappointment, ... just slow progress toward their goal. , Research from PsychTests.com reveals ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her son ... lash out at his family verbally and physically. , “When something upset him, he couldn’t ... would use it. He would throw rocks at my other children and say he was ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Comfort Keepers® ... American Cancer Society and the Road To Recovery® program to drive cancer patients to ... and other adults to ensure the highest quality of life and ongoing independence. ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute Beauty Network, ... M. Weintraub as a prominent plastic surgeon and the network’s newest partner. ... the most handsome men, look naturally attractive. Plastic surgery should be invisible.” He ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... According to a new market ... Needles, Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, ... of Purchase (Retail, Non-Retail) - Trends & Global Forecasts ... market for the forecast period of 2016 to 2021. ... by 2021 from USD 1.65 Billion in 2016, growing ...
(Date:6/23/2016)... , June 23, 2016 Research ... Devices Global Market - Forecast to 2022" report to ... the treatment method for the patients with kidney failure, it ... excess fluid from the patient,s blood and thus the treatment ... potassium and chloride in balance. Increasing number ...
(Date:6/23/2016)... -- Research and Markets has announced the addition ... - Forecast to 2022" report to their offering. ... to date financial data derived from varied research sources to ... potential impact on the market during the next five years, ... of sub markets, regional and country level analysis. The report ...
Breaking Medicine Technology: