FDA cracking down on quality lapses

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FDA's director of drugs, Janet Woodcock, said in September that she will personally direct the agency's latest push to advance pharmaceutical quality.

Speaking at a joint FDA/Parenteral Drug Association regulatory conference, Woodcock acknowledged disappointment in the slowness of her 10-year-old “GMPs for the 21st Century” initiative to boost manufacturing technology and quality.

She also said it seemed that industry's objective today is to meet regulatory standards, which are minimal expectations, versus adopting a commitment to high-quality medicines. “Innovators pay attention to R&D and not to making high quality drug products,” she told MM&M after her presentation.

The future of pharmaceutical manufacturing quality lies with continuous manufacturing principles and using new technologies to ensure quality, Woodcock told this year's industry attendees. “That is the revolutionary and transformative stuff, and within our reach, which it was not a decade ago,” she said.

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