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FDA public meeting

This article was originally published in The Tan Sheet

Executive Summary

FDA will hold a public meeting Feb. 7 to discuss potential revisions of chemistry, manufacturing and controls supplement regulations, the agency announces Jan. 5. "FDA is evaluating how it could revise its regulations to allow for consideration of risk-based approaches based on manufacturing process understanding, including prior-knowledge of similar products, and overall quality systems to provide an enhanced risk-based approach to the regulatory process, which would reduce the number of supplements," FDA writes. The agency is "considering redefining what FDA considers to be a major manufacturing change, reducing the reporting burden for certain changes, and creating a new reporting category of manufacturing changes that would not require notification to FDA." The decision is in line with FDA's Pharmaceutical Current Good Manufacturing Practices for the 21st Century Initiative (1"The Tan Sheet" July 3, 2006, p. 6). Comments should be submitted March 7...

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