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GMPs get the go-ahead...finally

This article was originally published in The Tan Sheet

Executive Summary

Office of Management & Budget clears proposed rule on dietary supplement Good Manufacturing Practices Jan. 16. Although reg will be released in the "near future," it may be a "a few weeks" before Federal Register publication, FDA says. Proposed rule has been on tortuous path since February 1997 advanced notice of proposed rulemaking. Reg has twice been returned to FDA by OMB; most recently proposal was sent to OMB Oct. 4...

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