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The FDA has signed a memorandum of understanding (MOU) with the Department of Veterans Affairs (VA) in which the two bodies will share information and expertise related to the review and use of devices, drugs and biologics.
After the FDA warned Tiara Medical Systems for several cGMP violations regarding its complaint-handling system, the company successfully responded to all agency citations, the FDA said.
FDA investigators found that Apple Medical’s procedures regarding its Fischer Cone Biopsy Excisors (FCBE), which are gynecologic electrocautery devices, violated several cGMP regulations, the agency said in a recent warning letter.
HemoSense's medical devices are adulterated due to cGMP violations regarding its complaint-handling and investigating system, an FDA warning letter said.
GE OEC Medical Systems, its parent company, General Electric (GE) — doing business as GE Healthcare — and two of GE’s top executives have signed an FDA consent decree of permanent injunction related to X-ray surgical imaging systems, the FDA said in a recent announcement.
An FDA program that encourages eligible device firms to pay accredited organizations to conduct their inspections rather than having the FDA conduct inspections for free may work better for larger firms than smaller ones, according to a new report.
The FDA warned Omnicare for inadequate quality control systems for the fifth time in 11 years, causing the company to recall its products and close its drug repackaging facility.
While the climate for drug safety reforms was thought to have improved with Democrats’ takeover of both chambers of Congress, the obstacles remain the same for drug safety legislation recently introduced by Sens. Chris Dodd (D-Conn.) and Chuck Grassley (R-Iowa), sources say.