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US FDA Progress Report Highlights Biomarkers, Continuous Manufacturing, Antibiotic Testing

 
• By Brenda Sandburg

Agency documents its regulatory science accomplishments to advance product development and manufacturing and ensure the safety and effectiveness of marketed products.

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While FDA regulatory actions capture headlines, the agency’s efforts to advance medical product development and manufacturing usually get little attention. That information is now available in a report listing the agency’s recent regulatory science accomplishments, which range from qualifying three new biomarkers for use in clinical trials to developing tools for studying continuous manufacturing.

FDA posted the document, “FY 2015-2016: Regulatory Science Progress Report,” on its website March 29. This is the...

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