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FDA's Decision-Making Process For ANDA Approval Standards Questioned In Vancomycin Case; Would Process Changes Alter The Outcome?

Executive Summary

ViroPharma has fired another shot across FDA's bow in the continuing battle over approval standards for generic oral vancomycin, charging in a petition supplement that the Office of Generic Drugs' decision to change bioequivalence methods for this antibiotic "was fraught with irregularities.

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