• Study: FDA Recall Communication System Ineffective, Poorly Designed

    It can be difficult to keep up with the dizzying number of drug recall notices sent by the US Food and Drug Administration (FDA). So difficult, in fact, that the agency seems to miss a significant number of recall notices itself, says a new study. The study, published in the Archives of Internal Medicine, finds FDA's recall information communication systems are sorely lacking, failing to disseminate information for as approximately 20% of all recalled medical products ...
  • Proposed Legislation Would Allow for Conditional Clearance of Medical Devices

    • 01 June 2012
    A new piece of legislation introduced in the House of Representatives on 30 May by Rep. Bruce Braley (D-IA) would give the US Food and Drug Administration (FDA) additional oversight of medical device recalls and allow certain medical devices to receive conditional clearance from the agency. Braley's bill, the Medical Device Patient Safety Act , is similar to a piece of legislation of the same name introduced in December 2011 in the Senate by Sens. Charles Grassley (...
  • FDA Looking to Speed up Public Notification of Recalls

    An item tucked within the US Food and Drug Administration's (FDA) weekly enforcement report indicates the agency is looking to speed up the way it notifies the general public regarding pharmaceutical recalls. FDA current publishes its recalls of all products in an extensive and sprawling document known as its Enforcement Report, which it publishes every Wednesday. The Enforcement Report is organized by product type and by the severity of the recall, but it is difficult t...