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CERTIFIED DATA SUMMARIES COULD BE POSSIBLE WITHOUT LEGISLATION, LASAGNA SUGGESTS AT HOUSE FDA OVERSIGHT HEARING; WAXMAN QUESTIONS NEED FOR BILL

Executive Summary

FDA could accept certified data summaries for preclinical and clinical trials for NDAs without new enabling legislation, Tufts Center for the Study of Drug Development Director Louis Lasagna, PhD, testified at a hearing before the House Commerce/Oversight Subcommittee June 19.
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