Content by Janet Woodcock, Judy McMeekin
FDA’s Ongoing Use of Inspectional Tools During the Covid-19 PandemicA flexible approach for ensuring access to safe, high-quality food and medical products
Thu, 04/29/2021 - 12:02
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 pandemic required us to rework our business…
FDA Proposes Process Modernization to Support New Drug DevelopmentIT and collaboration key to efforts
Wed, 06/13/2018 - 12:01
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 stature as the global “gold standard” in drug…
FDA Issues Final Guidance on Expedited Drug ApprovalsFour programs speed innovative treatments to market
Wed, 06/11/2014 - 14:23
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’ benefits outweigh their risks. Despite the progress,…