Article

What Is The Best Way To Keep Up With Changes In FDA Standards?

Source: WellSpring Pharma Services

By Anelis Aurand-Araos, Director of Scientific Affairs and Chief Compliance Officer, WellSpring

This is an interesting concept, one that actually goes by the name of “Regulatory Intelligence.”  Regulatory Intelligence (RI) is something that's really important because the standards are always evolving. In the United States, for example, they start at the top with the Federal Food Drug & Cosmetic Act, and recently, the Drug Quality and Security Act of 2013. FDA takes these laws and promulgates regulations and guidance documents to interpret those regulations.

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