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Six EU countries have successfully turned up the heat on sponsors who haven’t shared the findings of their clinical trials, a new analysis finds. But some member states still appear to be making little to no effort on trial transparency, threatening current efforts within the 27-nation trade bloc. Read More
Sally Choe, director of the FDA’s Office of Generic Drugs (OGD), will be stepping down from the agency on Oct. 8, and Susan Rosencrance, director of the Office of Lifecycle Products within the Office of Pharmaceutical Quality, has been tapped to replace her as acting OGD head. Read More
FDA leaders in oncology want sponsors seeking accelerated approval (AA) for cancer drugs to use new trial designs that will make the whole process more efficient and ultimately safer for patients. Read More
The FDA has published draft guidance outlining an ethical framework for involving children in clinical trials of drugs and devices, as well as trial design considerations. Read More