What’s in a name?
Executive Summary
Public workshop on premarket drug name safety testing, co-sponsored by FDA, the Pharmaceutical Research & Manufacturers of America, and the Institute for Safe Medication Practices, is scheduled for June 26. The meeting is being held to discuss ways to improve the process of premarket drug name testing for safety. FDA's draft "Premarketing Risk Assessment" concept paper proposes that sponsors conduct a "medication error prevention" analysis to assess the risk potential of the drug name prior to approval (1"The Pink Sheet" March 10, p. 5)...