FDA’s MANUFACTURING CHANGE REGULATIONS AND SUPPORTING GUIDANCE
This article was originally published in The Gold Sheet
Executive Summary
...are under review in the effort to alleviate the supplement burden on already marketed products. As FDA retools its quality regulatory paradigm, industry is affirming that focusing on creating a more risk-based and quality systems-oriented regulatory approach for manufacturing changes made to existing products could help spur firms down the quality-by-design pathway. Ideas that have been put on the table in response to an FDA request for industry input include: *a simplified, two-tier system requiring only supplements for high risk changes * reevaluating the format and content of annual reports and their relationship to annual product reviews * the importance of global harmonization, and * separate consideration of the API context. [Recommendations by PhRMA at an FDA meeting soliciting input on changing the 21 CFR 314.70 regulations are included. A summary of breakout discussions on the post-approval regulatory process at a recent FDA/AAPS/ISPE conference on the quality initiative is included.]
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