Article: FDA panel recommends action on Lotronex for irritable bowel syndrome.

Article: Risk management shapes FDA policies and ...
Pharmaceutical Technology North America;  August 1, 2002 ;     700+ words ... ... postapproval surveillance and risk management efforts. Reorganization addresses risk FDA's growing interest in risk management is apparent in several ... sidebar "Who's who in FDA risk management"). OPSS includes the ...

Article: Risk Management and Pricing Concerns Shaped ...
Biopharm International;  December 1, 2003 ;     700+ words ... ... medication safety problems. FDA held a three-day workshop ... April to examine how risk management approaches can promote ... reaches the market. FDA wants sponsors to do ... develop postmarketing risk management programs for drugs with ... increased safety concerns. FDA also is ...

Article: United BioSource Scientists, FDA, and Other Industry ...
PR Newswire;  November 19, 2008 ;     700+ words ... ... Policy, CDER, FDA; Claudia Karwoski ... director, Division of Risk Management Team, Office of ... effective global risk management and drug safety ... response to the FDA Amendments Act of ... Epidemiology and Risk Management, UBC, co-moderated ... called "How Does the FDA ...

Article: FDA's risk management workshop
Pharmaceutical Executive;  June 1, 2003 ;     700+ words ...FDA hosted a three-day ... feedback on its three risk management concept papers, which will eventually become FDA guidances that direct ... specifying goals for risk management programs (RMPs). FDA anticipates that, for ...

Article: FDA announces strengthened risk management ...
M2 Presswire;  August 12, 2005 ;     700+ words ...M2 PRESSWIRE-12 August 2005-US FDA: FDA announces strengthened risk management program to enhance safe use of Isotretinoin ... February 2004, at a joint meeting, FDA's Drug Safety and Risk Management Advisory Committee and Dermatologic ...

Article: PAREXEL Consulting Expands Risk Management ...
PR Newswire;  September 6, 2006 ;     700+ words ... ... brings 29 years of FDA pharmaceutical inspection ... the full range of risk management challenges facing ... by consultants with FDA crisis management and risk management backgrounds, with ... clients respond to FDA actions but also to ...

Article: 'Real time' QA is goal of FDA's efforts for 'quality by ...
Validation Times;  March 1, 2004 ;     700+ words ... ... Parexel, and former FDA field investigator ... the meeting that "risk management challenges are not ... opportunity while FDA is receptive ... Properly applied, risk management tools can yield ... key component of risk management is risk analysis ... biologics centers at ...