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Home » GPhA: BE STUDIES, INSPECTIONS MAY SLOW ANDA APPROVALS
GPhA: BE STUDIES, INSPECTIONS MAY SLOW ANDA APPROVALS
February 24, 2004
The Generic Pharmaceutical Association (GPhA) is questioning whether the FDA can find the additional time and personnel needed to comprehensively review additional in vivo bioequivalency (BE) data required of generic drugmakers under a proposed rule.