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One Step Back, Two Steps Forward to Improved Quality Processes

FDA has been encouraging drug manufacturers to tackle their batch-to-batch quality requirements for years, but is now getting serious about it. Historically reactive in its enforcement actions, FDA is now looking to proactively improve quality in the life-sciences industry. For example, rather than just punish companies for quality missteps, FDA is making plans to incentivize high-quality manufacturing in hopes that this will ensure better overall drug quality and a reduction in drug shortages.

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