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Two more drugs have been added to the list of those covered under a Medicare replacement drug demonstration project, according to the Centers for Medicare & Medicaid Services.
The FDA wants the U.S. senator leading an investigation into the possible suppression of study results linking antidepressant use and pediatric suicide to delay interrogating agency employees until after the FDA has completely investigated the matter.
An Italian firm was warned by the FDA this month for failing to meet quality system (QS) requirements in the manufacture of orthopedic medical devices.
Continuing a recent enforcement trend, the FDA last week published three new warning letters addressed to clinical trial operators.
The agency has issued a plethora of warnings to clinical investigators in recent months as part of an effort to crackdown on violations at universities and other research sites.
A pair of California devicemakers have found themselves under the FDA’s microscope — one for violating the quality system (QS) regulation and the other for marketing devices without premarket approval.
Cyberonics officials lashed out at the FDA last week after the agency issued a not-approvable ruling for the company’s implantable vagus nerve stimulation (VNS) therapy for patients with treatment-resistant depression. The ruling came roughly two months after an FDA advisory committee recommended approval of the device to treat depression.
The heated dispute between the FDA and devicemaker Utah Medical Products (UTMD) took a new turn last week when the government filed a injunction request in federal court Tuesday seeking to prevent the company from manufacturing or distributing its products until alleged quality violations are corrected.
Generic drugmaker Alpharma and OTC drug manufacturer Perrigo have agreed to a settlement with the FTC and various state attorneys general to end an investigation regarding an agreement that gave Perrigo a jump on marketing a children’s ibuprofen suspension product.