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The FDA’s long-awaited revision of Part 11, which is now slated for release in the first part of 2007, will impose major new burdens on the pharma industry in the area of risk assessment and management, according to Martin Browning, president of EduQuest and a former FDA official. Read More
A top FDA official said the agency is confident it can get Andrew von Eschenbach confirmed as the FDA commissioner by the end of the week, due to a growing understanding on the Hill of the need for permanent leadership at the agency. Read More
Andrew von Eschenbach’s nomination to be the next FDA commissioner remains stalled as the agency’s efforts to reach a compromise with a prominent lawmaker over access to an ongoing clinical trial investigation have failed. Read More
An FDA advisory panel is recommending that the anti-inflammatory drug Celebrex be approved for use in treating juvenile rheumatoid arthritis (JRA) despite a split among its members as to whether the drug would be safe in treating the disease. Read More
The FDA is calling on the pharmaceutical industry to help its regulatory project managers gain a greater understanding of the drug manufacturing process as part of its ongoing effort to bridge the information gap between industry and the agency. Read More