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Home » ViroPharma Says FDA's Bioequivalence Criteria Not Valid
ViroPharma Says FDA's Bioequivalence Criteria Not Valid
July 25, 2006
None of the criteria the FDA’s Office of Generic Drugs (OGD) uses to determine whether it can issue a clinical trial waiver for a generic drug are applicable to ViroPharma’s gastrointestinal antibiotic Vancocin, company executives said July 13.