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Rep. Rosa DeLauro (D-Conn.), a frequent critic of the FDA’s drug safety system, has seized on a recent agency report as evidence that the agency’s postmarketing efforts are failing, but industry and activists are skeptical of her reasoning.
A recently published FDA guidance provides detailed information on what firms need to include in premarket notification, or 510(k), applications for cord blood processing systems and storage containers.
The FDA warned Lee Laboratories for several current good manufacturing practice (cGMP) violations, most of which were repeat violations from a previous agency inspection.
The FDA has warned Applied Water Engineering for manufacturing its dialysis devices without conducting quality audits or performing necessary complaint response procedures. One of the firm's devices also lacked premarket approval, the agency said.
A newly published survey suggests orthopedists want to see a shorter device approval process at the FDA as well as changes to existing laws to make unapproved products more easily available to consumers.
The FDA sent the Craftmatic Organization a warning letter for failing to handle and report product complaints, but the company said it should not have received the letter because it did not manufacture the devices.
An FDA advisory panel was unable to give its vote of confidence to a new device meant to treat severe depression last month. This leaves Cyberonics’ vagus nerve stimulation (VNS) therapy to dominate the U.S. market for emerging alternative treatments to currently accepted electroconvulsive therapy (ECT), an analyst says
When deciding which type of FDA marketing application to submit, device firms should consider the possibility they may have to defend themselves against civil, or "tort," lawsuits if their products are linked with patient injury, legal experts told attendees at an FDAnews audioconference last month.
The FDA wants to impose new electronic reporting requirements on biological product manufacturers to assist in potential product recalls, the agency said.
The FDA acknowledged the need for greater transparency and an increased focus on safety in its drug review process through a series of recommendations it issued last week.