In Focus: FDAAA Update

| 01 May 2009

On 27 September 2007, President George W Bush signed into law HR 3580, the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA, which included at least 200 new provisions, represented the most comprehensive reform of prescription drug regulation to occur in decades. The act greatly increased and expanded the responsibilities of FDA and reauthorized a number of critical programs. Every facet of development and commercialization-from pediatric research, labeling rules, postmarketing surveillance requirements, risk evaluation and mitigation, and direct to-consumer advertising through marketing, to name just a few-was impacted. The FDA commissioner welcomed the new legislation, seeing it as an opportunity for the agency to better serve the public in its role of promoting and protecting public health. Meanwhile the pharmaceutical/biotech industry braced itself for the changes to the regulatory landscape FDAAA would bring.


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