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This established a group of 1465 trials covered by the FDAAA, for which more than a year had passed since completion in which to report results.Flow diagram to show selection of trialsOpen in new tabReporting for applicable trials is (at present) mandatory only for drugs, biological agents, or devices approved by the FDA. APP categorised drugs from trials as previously approved by the FDA. MNH repeated this classification for a sample of 150 (10%) of the records.
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