Manufacturing Industry
FDA eases approval rules for drug makers.(Industry Newsline)
Industrial Maintenance & Plant Operation, October, 2004
Under new guidelines designed to prevent supply disruptions, drug makers will not need regulatory approval for every change in their manufacturing processes, the U.S. Food and Drug Administration said last month. In a report detailing its two-year effort to overhaul pharmaceutical regulation, the FDA said drug makers 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.
According to a Reuters report, drug makers had complained that previous requirements caused delays in new-medicine approval. It added that while the changes will get products to market more quickly, critics see them as decreased regulation that could harm patients. The changes will...
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