Food and Drug Administration Amendments Act (FDAAA)

The Food and Drug Administration Amendments Act (FDAAA) is a law passed in 2007 that enhances the FDA’s authority to ensure the safety and effectiveness of medications and medical devices. It requires more rigorous clinical trial oversight, mandates the registration and results reporting of certain trials on public databases, and authorizes penalties for non-compliance. Overall, FDAAA aims to improve transparency, protect public health, and ensure that consumers and healthcare professionals have access to accurate, timely information about new drugs and treatments.