191055 FDA's Drug Safety Initiative

Monday, October 27, 2008: 10:50 AM

Sandra Kweder, MD , Office of New Drugs, Food and Drug Administration, Silver Spring, MD
     
The presentation will describe changes in the oversight of drug safety since the enactment of the Food and Drug Administration Amendments of 2007, or FDAA. These include the use of post-marketing surveillance studies and of quantitative tools to assess and manage risks, and the development of a safety modernization plan for the federal agency.

Learning Objectives:
1. Discuss the extent of the drug safety initiatives overseen by the FDA following enactment of the FDAA. 2. Identify the quantitative tools being used to assess drug safety risk post-marketing.

Keywords: Drugs, Safety

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: tba
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.

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