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Manufacturing Regulation BioPharmaceutical

FDA Makes 'Significant Changes' To Drug Registration Rules

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Executive Summary

FDA on Sept. 1 issued a final rule that requires firms to electronically submit drug registration information and clarifies who must register their establishments. The final rule goes into effect on Nov. 30, more than 10 years first proposed.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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