September 14, 2009 | Food and Drug Law Journal, Vol. 64, No. 3
The article provides a summary of the expansion in FDA’s discretionary authority in the post-9/11 period, particularly with respect to FDA’s postmarket authority to monitor and publicize potential health risks linked to food, dietary supplements, nonprescription drugs, and other consumer health products. In addition, the article evaluates the need for FDA to establish procedural safeguards to reduce the significant risks of unintended and undue harm to people and regulated companies that can result from adverse publicity in the more “transparent” post-9/11 FDA regulatory environment.With permission from FDLI.
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