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FDA new rule would make generic drug companies accountable for safety of their drugs

The Food and Drug Administration (FDA) is seeking a new rule to close a loophole that prevents manufacturers of generic drugs from adequately warning patients of potentially harmful side effects, and the public is encouraged to weigh in on the plan. About 80 percent of all prescription drugs sold today are generic versions of brand-name drugs. Generics are required to bear the same safety labels as their branded counterparts. However, manufacturers of generic drugs cannot by law independently update their labels if the company becomes aware of new information about the drug, nor can they be held accountable if their ... Read More

Feds approve new tracking process for medical devices

Medical devices will now be manufactured with a code that will help them be tracked in order to gauge safety issues and notify recipients in the event of a recall as part of a new rule passed this week by federal regulators. The new process assigns a unique device identifier, or UDI, to each device, which provides basic information such as manufacturer name, type of device, model, and expiration date. Some devices may include batch lot numbers to help identify devices in the event of a recall. UDI information will be stored in a database that is accessible to the public; ... Read More