ARTICLES BY BARBARA UNGER
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What Risk Factors Does The FDA Consider In Scheduling Drug GMP Inspections?9/27/2018
The globalization of the supply chain has expanded the scope of sites the FDA must routinely inspect from those in the U.S. to facilities worldwide.
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An Analysis Of 2017 FDA Warning Letters On Data Integrity5/18/2018
Enforcement of failures in data integrity and data governance began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. While the FDA is not the only health authority that identifies these issues in inspections and enforcement actions, its transparency ensures the data is available.
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