FDA Faces Mounting Pressure on Shortcut Approval Pathway
The FDA has recently come under fire by big pharma and big biotech. The issue: FDA's interpretation of a section of the Federal Food, Drug, and Cosmetic Act-505(b)(2)-which allows companies to rely on data other than their own to attain drug approval.
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Nothing Random About It: The State of Cancer Drug Development at FDA
FDA is getting tougher on cancer drug approvals. But stakeholders on all sides-industry, regulators, and patient groups-say that's probably a good thing. Under the leadership of Richard Pazdur, MD, the controversial director of FDA's newly formed Office of Oncology Drug Products, the agency is raising the bar for getting cancer drugs on the market.
Shadow FDA? Researchers Are Taking Approval Matters into their Own Hands
Drug and biotech companies will face an emerging trend of outside interference on pending drug reviews at FDA. The events surrounding the final outcome of FDA's review of Bristol-Myers Squibb and Merck's diabetes drug muraglitazar (Pargluva) signal that outside medical centers and prominent researchers will voluntarily play a larger role in drug safety oversight in the future.
Flying Through FDA: Test Runs For Pilot 1
FDA's Pilot 1 rolling review process has led to accelerated approvals for cutting edge therapies. In addition to smaller biotechs, some of the largest pharmaceutical companies in the world are using it - and having success. FDA's top drug reviewer tells you how to maximize the value of the temporary program.