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:4/28/2017)... ... 2017 , ... Accreditation Commission for Health Care (ACHC) is ... (HCAOA). This agreement allows HCAOA members to receive special pricing on ACHC’s Home ... University (AU) educational resources that help prepare HCAOA members for ACHC Accreditation. , ...
(Date:4/28/2017)... Clara, CA (PRWEB) , ... April 28, 2017 ... ... is pleased to announce the integration of Microsoft(R) Word(TM) Online(TM), which enables sleep ... user experience, since it streamlines the reporting process and provides a familiar interface ...
(Date:4/28/2017)... ... ... Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ) announced today that ... as “stable.” At the same time, the ratings agency cautioned that the company’s rating ... “capital adequacy” thresholds required for its strong rating. , “Horizon is committed to being ...
(Date:4/28/2017)... ... April 28, 2017 , ... GlycoMark, ... the GlycoMark test throughout the Northeast U.S. , GlycoMark is the only ... The GlycoMark test provides a clinically proven one- to two-week measure of hyperglycemic ...
(Date:4/28/2017)... ... 2017 , ... Ushio America proudly introduces the new ... solution for F32T8 fluorescent lamps on most instant-start and programmed-start electronic ballasts so ... lamps utilize the existing electronic ballast, saving labor and maintenance costs. It’s easy ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... --  ZappRx, Inc ., a digital health company focused on ... it closed $25 million in Series B funding led by ... Seattle that is part of a ... B round included participation from SR One , who ... (formerly Google Ventures). As part of the financing, ...
(Date:4/20/2017)... , April 20, 2017 Eyevensys, ... the first non-viral gene expression technology that enables the ... eye to address a wide range of ophthalmic diseases, ... and Healthcare products Regulatory Agency (MHRA) to advance its ... ...
(Date:4/19/2017)... - CRH Medical Corporation (TSX: CRH) (NYSE MKT: CRHM) (the "Company"), announces that ... Conference 2017 at the Sheraton Hotel in Toronto, Ontario ... of the Company is scheduled to present on Tuesday, May 2 ... the Chairman of the Board, Tony Holler will also ... For more ...
Breaking Medicine Technology: