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Home » ADDITIONAL BE STUDIES, INSPECTIONS MAY SLOW ANDA APPROVALS
ADDITIONAL BE STUDIES, INSPECTIONS MAY SLOW ANDA APPROVALS
February 11, 2004
Critics of the FDA’s proposed rule on in vivo bioequivalence (BE) data are wondering whether the agency can find the additional time and personnel needed to comprehensively review drugmakers’ BE data submitted in abbreviated new drug applications (ANDAs).