Law360, New York (October 21, 2009) -- On Sept. 30, 2009, the U.S. Food and Drug Administration released a draft of its Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications.
Although the FDA refers to the guidance as a draft, the document offers insight into the agency's current thinking about risk management for certain drug and biological products....
