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NDA AND ANDA QUALITY ASSESSMENT PILOT PROGRAMS

This article was originally published in The Gold Sheet

Executive Summary

...are being launched that will help transform the way CMC information is submitted and reviewed in the U.S. The new NDA and ANDA pilots are intended to better focus CMC reviews on the design, development and manufacturing science behind quality, resulting in more effective and efficient regulatory and manufacturing processes. On the NDA side, FDA’s Office of New Drug Chemistry intends to work hand in hand with volunteer companies in developing and clearing a dozen applications that will embody the principles of quality by design, product knowledge and process understanding central to the new regulatory paradigm. The Office of Generic Drugs, meanwhile, is launching an ANDA "question-based review" model that will drive both applicants and reviewers to focus directly on what is most critical to the quality assessment process. The pilots will be accompanied by a workshop in early October to debate the relevant challenges and issues and help target the new CMC review procedures and guidance.

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