FDA’s Lawrence Yu to Participate in Live Video Chat on Question-Based Review (QbR) for Generics on CPhI Pharma Evolution
NEW YORK, Aug. 20, 2013 /PRNewswire/ — On Thursday, August 22, at 10:00 a.m. ET, FDA’s Lawrence Yu, PhD, will take part in an hour-long video chat on CPhI Pharma Evolution, to discuss the QbR process and address pharma professionals’ questions on the initiative and what it means for generic drug manufacturers.
The FDA’s Question-Based Review process for generic drugs brings more modern principles from the FDA’s cGMPs for the 21(st) century initiative into CMC evaluations for ANDAs. The process was developed to ensure that what is most critical to final product quality is prioritized in generic drug development, and brings more of the science-based approach found in NDA review to ANDAs. It also aims to have generic manufacturers demonstrate more effective and efficient manufacturing and scale-up approaches, and to integrate the fundamental principles of pharmaceutical QbD into their drug development programs.
Yu, who was instrumental in developing the QbD process, was formerly Director of Science in the FDA’s Office of Generic Drugs, is now Acting Deputy Director of its Office of Pharmaceutical Science, and oversees the FDA’s Office of New Drug Quality Assessment, Office of Generic Drug Quality Assessment, Office of Biotechnology Products, and Office of Testing and Research.
For more information and to participate in the live video chat, click here: http://www.pharmaevolution.com/video-stream.asp?section_id=3043&doc_id=560782
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SOURCE CPhI Pharma Evolution