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The FDA has issued a warning letter to a Czech Republic-based manufacturer, alleging that the firm failed to properly test one of its products and violated the agency’s Quality System Regulation (QSR) for medical devices.
A botched series of inspections may be to blame for the budding rift between the FDA and Utah Medical Products (UTMD), according to Edward McDonnell, the former district director of the FDA’s New England District.
Recent enforcement actions against two devicemakers indicate that the FDA is keeping a close watch on marketing efforts, particularly if they tout products for uncleared indications.
Including race and ethnicity data on FDA MedWatch forms could hinder companies’ postmarket adverse event reporting efforts and be of little scientific value, according to comments recently submitted to the agency.
Continuing its enforcement efforts against companies that facilitate drug reimportation, the FDA has issued a warning letter to a storefront operation it accused of violating federal law by working with a Canadian internet pharmacy to import lower-cost Rx drugs.
Pfizer has directed its authorized wholesalers and distributors in Canada to stop supplying the company’s drugs to a number of pharmacies that sell the products to patients in the U.S. through internet sites or other means.
A pair of U.S. senators may hold up the confirmation of FDA Commissioner Mark McClellan as head of the Centers for Medicare & Medicaid Services unless he answers questions about the agency’s opposition to the reimportation of drugs.
The FDA announced a shuffling of leadership at the agency following the announcement that FDA Commissioner Mark McClellan has been nominated to head the Centers for Medicare & Medicaid Services (CMS).