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NEW MANUFACTURING CHANGE REGULATIONS

This article was originally published in The Gold Sheet

Executive Summary

...and supporting guidance are emerging from FDA under pressure to meet tight FDAMA timelines. A final guidance detailing the agency’s interpretation of the new regulations is expected to be completed in 1999, with the final 314.70 rule to follow next year. The agency does not intend to overhaul the companion guidance in spite of a perceived lack of regulatory relief in the proposed draft, although some adjustments are being made relating, for example, to compendial revisions and sterile products. FDA and industry are gaining experience with comparability protocols as a mechanism for expediting manufacturing changes. [A discussion by a center for biologics official of successful comparability protocol filings is included beginning on p. 11.]

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