FDA Featured Articles
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Three Questions To Consider For DQSA Readiness
By Dave Colombo and Dawn Wang, KPMG Life Sciences Advisory
Last November, after much anticipation, the U.S. pharmaceutical industry saw the enactment of the Drug Quality and Security Act (DQSA), which includes in Title II the Drug Supply Chain Security Act (DSCSA). The DSCSA addresses national pharmaceutical track and trace requirements, and industry stakeholders must now prepare themselves for the first round of deadlines for lot-level traceability starting January 1, 2015. In preparation for these guidelines, it is important for companies to follow a framework as they assess their organizations’ readiness to meet DSCSA compliance. A successful program will do so by evaluating the impacts to their business processes and governance, technical solutions, and trading partner relationships.
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Quality Metrics: How To Add Value And Meet The FDA's Expectations
Establishing and utilizing quality metrics is essential for the pharma industry's future success. Learn how to identify meaningful metrics and appropriately measure quality to make better business decisions.
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What Is The Best Way To Keep Up With Changes In FDA Standards?
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.