A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
The Medicines and Healthcare products Regulatory Agency issued a field safety notice for Hospira’s Plum A+ infusion pump due to a possible delay in therapy caused by continuous recycling and/or rebooting if the LED display settings are adjusted from the original default settings.