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Home » CRITICS FEAR MORE BE STUDIES MAY SLOW ANDA APPROVALS
CRITICS FEAR MORE BE STUDIES MAY SLOW ANDA APPROVALS
February 13, 2004
Some critics are wondering whether the FDA has the time and people the agency needs to process the additional data it is requesting in its proposed rule on in vivo bioequivalence (BE) data submitted in abbreviated new drug applications (ANDAs).