The rules governing FDA-regulated clinical studies to test unapproved drugs will undergo a revision, with proposed new language expected out next spring, according to the latest regulatory agenda.
The proposed rule was part of the Department of Health and Human Services regulatory agenda, which is a compilation released twice a year of the rulemaking activities expected for the foreseeable future. Many items in the agenda, released May 18, including the proposed new Common Rule and ClinicalTrials.gov reporting requirements, have carried over from the agenda released in November9 LSLR 24, 12/11/15, 14 MRLR 788, 12/2/15.
But the Food ...
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