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Key Points
Audio Transcript
To better understand the importance of FDA drug approval as well as the process for seeking approval, it is helpful to learn the background and definitions of FDA regulation of drugs. I will briefly explain how the legal framework for drug approval has changed over time, and will define some commonly misunderstood terms that have been part of those changes.
For a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally in the United States without the required FDA approval. This problem has evolved into an even bigger problem as the country's drug approval laws have changed.