Reg updates to challenge manufacturers

While the FDA studies up on nanotechnology and stem cells, assuming its 2011 budget request is approved (see related story), the regulator will simultaneously update its drug review processes. The "Advancing Regulatory Science" initiative aims to modernize its product evaluation standards.

The FDA describes regulatory science as "unique and different from science conducted by industry and academia," according to the budget request. "FDA will support applied science that focuses on product characterization tools and biomarkers for product safety and effectiveness."

One result may be an increase in both foreign and domestic facility inspections, says Ron Kraus, VP for global customer strategy at PAREXEL Consulting. "Enforcement actions will be swift and aggressive," he says via email. He also expects an increase in the overall number of warning letters.

Another likely effect: The initiative may encourage biopharmaceutical companies to become even more proactive with regard to their strategic compliance activities, says Kraus.

- here's the budget request


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