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Manufacturers and assemblers of x-ray computed tomography (CT) equipment may use an alternate measure of the computed tomography dose index (CTDI) when scanning patients, a new FDA guidance says. Read More
Miltronics & Skye violated several current good manufacturing practice (cGMP) regulations in making its implantable orthopedic devices, according to an FDA warning letter. Read More
A devicemaker facing potential problems after an FDA inspection would be well served by clearly and promptly corresponding with the agency, according to an FDA official speaking at an FDAnews conference last month. Read More
Sen. Chuck Grassley (R-Iowa) is questioning whether the Bush administration’s nominee to be FDA commissioner, Andrew von Eschenbach, issued veiled threats against agency employees who might speak out against FDA policies. Read More
The Bush administration is resisting a federal court order to provide documents relating to its alleged influence over FDA decisionmaking regarding the controversial contraceptive Plan B, citing separation of power concerns and claiming lack of relevance. 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
The FDA is looking into ultimately moving to an all-electronic submission system for regulatory information in all its divisions and will hold a public hearing on the proposal this month. Read More