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Protecting the Global Drug Supply

Implementing Title VII of the FDASIA

Howard Sklamberg
Wed, 07/23/2014 - 16:35
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Since July 9, 2012, when President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA), a group of colleagues and I have had an urgent mission: implement Title VII of the statute. This section gave the FDA new authority to better protect the global drug supply chain, which is a critically important public health task in an increasingly global marketplace.

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Title VII will advance the FDA’s transformation into a global public health agency, primarily by enabling it to better oversee the safety and integrity of drug ingredients and finished drugs in the supply chain. Thanks to this law, the FDA can become better informed about supply chain risks. This information allows the FDA to target its resources to higher-risk facilities, which makes us both more efficient and more effective in further ensuring the quality and safety of drug ingredients and finished drugs. The law also provides us with important new enforcement tools and facilitates our cooperation with trusted foreign regulators, which is essential in a global marketplace.

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