Drug makers will not need regulatory approval for every change in their manufacturing processes under new guidelines designed to prevent supply disruptions, U.S. health officials said on Wednesday. Companies can skip the prior approval requirement if they have developed adequate tests and procedures to show certain changes will not affect product safety or effectiveness, the Food and Drug Administration (News - Websites) said in a report.The modification is part of a just-completed, two-year effort to overhaul regulation of pharmaceutical manufacturing, a major issue for drug makers.
