FDA BIANNUAL ADVERSE EVENT REPORTING PROPOSAL POSES IMPEDIMENT TO DRUG DEVELOPMENT, IoM FIAU REPORT SAYS; STUDY INVESTIGATORS ARE EXONERATED
An FDA proposal to require biannual reports on deaths and serious adverse experiences in clinical studies of investigational agents would pose an impediment to drug development that might outweigh safety benefits, a March 16 Institute of Medicine report on the FIAU clinical trials maintains.
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