STAT and trade publications reported that the committee recommended six of seven nominated peptides for the 503A bulks list and voted against emideltide/DSIP. Vote tallies disagree in places between outlets. FDA staff, per those reports, had recommended against adding the substances.
Until minutes and any rulemaking are on FDA’s site, Therapept treats those reports as news, not as a change to identity-record status. Withdrawn nominations remain withdrawn nominations in the library.
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