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The version of user fee legislation that’s slated to be attached to a continuing resolution (CR) later this week — just days before the end of the fiscal year — is devoid of any riders House of Representatives members and Senators worked to attach to it over the summer. Read More
The FDA reprimanded Jerome Stevens Pharmaceuticals in a Form 483 for inadequate validation studies and other deficiencies observed during an inspection of its Bohemia, N.Y., plant from May 25 to June 15. Read More
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