FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Common Rule Revisions Delayed for Six Months, But Certain Changes Can Continue

Jan. 22, 2018
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The federal government pushed back its revisions to the Common Rule for an additional six months — making the announcement less than 36 hours before the changes were set to take effect Jan. 19 — and warned the public to expect additional delays down the line.

The Common Rule encompasses the federal regulations and policies that govern the protection of human research subjects, including informed consent procedures and institutional review boards, and spans at least 16 departments and agencies.

The new implementation date is currently set for July 19 — but HHS, the Consumer Product Safety Commission and the Environmental Protection Agency, as well as the departments of Veterans Affairs, Defense, Commerce and others, are all currently developing a new proposed rule to further delay the changes, which were first announced in January 2017.

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