Food and Drug Administration Amendments Act

The Food and Drug Administration Amendments Act (FDAAA), enacted in 2007, strengthened the FDA's authority to oversee drug and medical device safety. It requires more rigorous testing and monitoring of products before and after market approval. The Act aims to improve patient safety, enhance the transparency of clinical trial information, and ensure that consumers receive important safety updates. It also mandates the establishment of a system for tracking adverse events and promotes public access to drug information, reinforcing the commitment to safeguard public health and ensure the efficacy of medical treatments.