Content by Janet Woodcock

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FDA’s Ongoing Use of Inspectional Tools During the Covid-19 Pandemic
Janet Woodcock
During the past year, the U.S. Food and Drug Administration’s (FDA) approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate. The Covid-19...
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FDA Proposes Process Modernization to Support New Drug Development
Janet Woodcock
The staff of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) always tries to utilize cutting-edge science and up-to-date process management, befitting our...
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FDA Issues Final Guidance on Expedited Drug Approvals
Janet Woodcock
In recent years, there have been important advances to ensure that therapies for serious conditions are approved and available to patients as soon as sufficient data can show that the therapies’...