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Compliance In Focus
Posted by John Lehmann on Tue, Sep 18, 2012

FDA: Why Care about Regulatory Science?

Regulatory ScienceFDA recently made updates to its webpage titled, “Why You Should Care About Regulatory Science” with the goal of better informing the public about this growing field which impacts the life of the average consumer. In fact, Margaret Hamburg, FDA Commissioner, points out that “FDA’s regulatory oversight is extraordinary, touching the lives of every American, through the food we eat, the medicines we take, and the medical devices we use.”

So, what exactly is regulatory science? Despite the obvious science words that might be top of mind (like biology, ecology, chemistry, etc.) this science deals with “developing new tools, standards and approaches to assess the safety, effectiveness, quality and performance of FDA-regulated products.”

How does this affect the average person? FDA’s website provides links and requests readers to explore how regulatory science affects everyday life with topics like:

While our industry has a strong focus on the regulatory science regarding new technologies, it’s good to be reminded that we’re part of a larger framework and each part shares a common goal- protecting people. Regarding medical devices, CDRH relies heavily on regulatory science to ensure public safety while bringing innovative products to market.

What do you think about FDA’s goal of informing the public on regulatory science? Do you appreciate this field and the investments that are made in this area of science? Let us know your thoughts.

Photo Credit: Leo Reynolds

Topics: Margaret Hamburg, Regulatory Science, FDA


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